Fluocinolone (Topical)

• Fluocinolone Acetonide

Excipient information presented when available (limited, particularly for generics); consult specific product labeling.

Cream, External, as acetonide:

Synalar: 0.025% (120 g) [contains cetyl alcohol, edetate disodium, methylparaben, propylene glycol, propylparaben]

Generic: 0.01% (15 g, 60 g); 0.025% (15 g, 60 g)

Kit, External, as acetonide:

Synalar (Cream): 0.025% [contains cetyl alcohol, edetate disodium, methylparaben, propylene glycol, propylparaben]

Synalar (Ointment): 0.025%

Synalar TS: 0.01% [contains propylene glycol]

Xilapak: 0.01% [contains butylparaben, cetyl alcohol, methylparaben, propylene glycol, propylparaben]

Oil, External, as acetonide:

Derma-Smoothe/FS Body: 0.01% (118.28 mL) [contains isopropyl alcohol, peanut oil]

Derma-Smoothe/FS Scalp: 0.01% (118.28 mL) [contains isopropyl alcohol, peanut oil]

Fluocinolone Acetonide Body: 0.01% (118.28 mL) [contains isopropyl alcohol, peanut oil]

Fluocinolone Acetonide Scalp: 0.01% (118.28 mL) [contains isopropyl alcohol, peanut oil]

Ointment, External, as acetonide:

Synalar: 0.025% (120 g)

Generic: 0.025% (15 g, 60 g)

Shampoo, External, as acetonide:

Capex: 0.01% (120 mL)

Solution, External, as acetonide:

Synalar: 0.01% (60 mL, 90 mL) [contains propylene glycol]

Generic: 0.01% (60 mL)

There are no dosage adjustments provided in the manufacturer's labeling.

Follow all directions on your prescription label. Do not use this medicine in larger or smaller amounts or for longer than recommended. Topical steroid medicine can be absorbed through the skin, which may cause steroid side effects throughout the body.

Do not cover treated skin areas with a bandage or other covering unless your doctor has told you to. If you are treating the diaper area of a baby, do not use plastic pants or tight-fitting diapers.

Covering the skin that is treated with fluocinolone topical can increase the amount of medicine your skin absorbs, which may lead to unwanted side effects. However, plastic film covering (such as plastic wrap or a shower cap) is sometimes used when treating psoriasis. Follow your doctor's instructions.

Wash your hands before and after using fluocinolone topical, unless you are using the medication to treat the skin on your hands.

Apply a small amount of the medicine to the affected area and rub it gently into the skin. Do not use this medication over a large area of skin.

If you are using the shampoo form of this medication, apply a small amount (1 ounce or less) to wet hair and work into a lather. Leave the shampoo on the scalp for 5 minutes and then rinse thoroughly.

Call your doctor if your symptoms do not improve, if they get worse, or if you develop signs of a skin infection.

If you use this medication long-term, you may need frequent medical tests at your doctor's office.

Store at room temperature away from moisture and heat. Keep the bottle tightly closed when not in use.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

An overdose of fluocinolone topical is not expected to produce life threatening symptoms. However, long term use of high steroid doses can lead to symptoms such as thinning skin, easy bruising, changes in the shape or location of body fat (especially in your face, neck, back, and waist), increased acne or facial hair, menstrual problems, impotence, or loss of interest in sex.

Do not use this medicine to treat any skin condition that has not been checked by your doctor.

If this medication gets in your eyes, rinse with water. Do not use fluocinolone topical on broken or infected skin, or in an open wound.

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Stop using this medication and call your doctor at once if you have severe irritation of any treated skin, or if you show signs of absorbing fluocinolone topical through your skin, such as:

• blurred vision, headache;

• thinning skin, easy bruising;

• mood changes;

• weight gain, puffiness in your face; or

• muscle weakness, feeling tired.

Common side effects may include:

• mild skin itching, burning, peeling, or dryness;

• thinning or softening of your skin;

• swollen hair follicles;

• blisters, pimples, or crusting of treated skin;

• changes in color of treated skin;

• skin rash or irritation around your mouth; or

• stretch marks.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Usual Adult Dose for Seborrheic Dermatitis:

No more than one ounce of the shampoo should be applied to the scalp area once a day, worked into a lather and allowed to remain on the scalp for approximately 5 minutes

Comments:
-Hair and scalp should be rinsed thoroughly with water.

Use: Treatment of seborrheic dermatitis of the scalp

Usual Adult Dose for Psoriasis:

Apply a thin film on the scalp, massage well and cover scalp with the supplied shower cap.

Comments:
-Wet or dampen hair and scalp thoroughly
-Leave the oil on overnight or for a minimum of 4 hours before washing it off
-Wash hair with regular shampoo and rinse thoroughly

Use: Treatment of psoriasis of the scalp

Usual Adult Dose for Dermatitis:

Apply a thin film to the affected area two to four times a day

Comments:
-Occlusive dressings may be used for the management of psoriasis or recalcitrant conditions.
-If an infection occurs, the use of occlusive dressings should be discontinued and appropriate antimicrobial therapy initiated.

Use: Relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses

Usual Adult Dose for Eczema:

Apply a thin film to the affected area two to four times a day

Comments:
-Occlusive dressings may be used for the management of psoriasis or recalcitrant conditions.
-If an infection occurs, the use of occlusive dressings should be discontinued and appropriate antimicrobial therapy initiated.

Use: Relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses

Usual Adult Dose for Atopic Dermatitis:

Topical (body) oil: Apply a thin film to the affected areas three times a day

Comments:
-Use should be discontinued when control of disease is achieved.
-If no improvement is seen within 2 weeks, a healthcare provider should be contacted.

Use: Treatment of atopic dermatitis

Usual Pediatric Dose for Atopic Dermatitis:

3 months and older:
Topical (scalp and body) oil: Apply to affected area twice a day for up to 4 weeks

Comments:
-The oil should not be applied to the diaper area.
-Intertriginous areas should be avoided.
-Safety and effectiveness in pediatric patients younger than 3 months of age have not been established.

Use: Treatment of moderate to severe atopic dermatitis

Usual Pediatric Dose for Seborrheic Dermatitis:

No more than one ounce of the shampoo should be applied to the scalp area once a day, worked into a lather and allowed to remain on the scalp for approximately 5 minutes

Comments:
-Safety and effectiveness in children and infants have not been established.
-Hair and scalp should be rinsed thoroughly with water.

Use: Treatment of seborrheic dermatitis of the scalp

Usual Pediatric Dose for Dermatitis:

Apply a thin film to the affected area two to four times a day

Comments:
-Pediatric patients may demonstrate greater susceptibility to topical corticosteroid-induced HPA axis suppression and Cushing's syndrome than mature patients because of a larger skin surface area to body weight ratio.
-Occlusive dressings may be used for the management of psoriasis or recalcitrant conditions.
-If an infection occurs, the use of occlusive dressings should be discontinued and appropriate antimicrobial therapy initiated.

Use: Relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses

Usual Pediatric Dose for Eczema:

Apply a thin film to the affected area two to four times a day

Comments:
-Pediatric patients may demonstrate greater susceptibility to topical corticosteroid-induced HPA axis suppression and Cushing's syndrome than mature patients because of a larger skin surface area to body weight ratio.
-Occlusive dressings may be used for the management of psoriasis or recalcitrant conditions.
-If an infection occurs, the use of occlusive dressings should be discontinued and appropriate antimicrobial therapy initiated.

Use: Relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses

It is not likely that other drugs you take orally or inject will have an effect on topically applied fluocinolone. But many drugs can interact with each other. Tell each of your health care providers about all medicines you use, including prescription and over-the-counter medicines, vitamins, and herbal products.

This shampoo is used to treat severe dandruff (seborrheic dermatitis). Fluocinolone reduces the swelling, itching, flaking, and redness that can occur with dandruff. This medication is a low- to medium-strength corticosteroid.

How to use Fluocinolone Shampoo

This shampoo comes with a capsule of medication that the pharmacist must add to the shampoo before giving you this product. Once prepared, shake well before each use. Apply about one ounce of the shampoo to the scalp once daily by working into a lather. Allow it to remain on the scalp for 5 minutes. Then thoroughly rinse your scalp and hair two times. Also rinse any other body parts (e.g., hands, face, neck, shoulders) that may have come in contact with the shampoo.

Do not bandage, wrap or cover the affected area (e.g., avoid using shower caps or bathing caps) unless directed by your doctor.

This shampoo should be used only on the scalp. Do not apply this medication to your face, neck, groin, or underarms. After applying the medication, wash your hands. Avoid getting this medication in the eyes, nose, or mouth. If you get the medication in these areas, rinse with plenty of water.

Do not use this medication more often or for a longer period than prescribed because the risk of side effects may be increased. Inform your doctor if your condition persists or worsens after 2 weeks.