HC DermaPax

• Tell all of your health care providers that you take this medicine. This includes your doctors, nurses, pharmacists, and dentists.
• Do not use with other products that have diphenhydramine.
• Do not use to treat diaper rash.
• If signs get worse or last for more than 7 days, talk with the doctor.
• This medicine may cause harm if swallowed. If HC DermaPax is swallowed, call a doctor or poison control center right away.
• Talk with the doctor before giving this medicine to a child younger than 2 years of age.
• Tell your doctor if you are pregnant or plan on getting pregnant. You will need to talk about the benefits and risks of using HC DermaPax while you are pregnant.
• Tell your doctor if you are breast-feeding. You will need to talk about any risks to your baby.

Use this medicine as ordered by your doctor. Read all information given to you. Follow all instructions closely.

• Do not take HC DermaPax by mouth. Use on your skin only. Keep out of your mouth and eyes (may burn).
• Wash hands before and after use.
• Wash affected skin and pat dry.
• Put a thin layer on the affected part.

What do I do if I miss a dose?

• Many times this medicine is used on an as needed basis. Do not use more often than told by the doctor.

• If your symptoms or health problems do not get better or if they become worse, call your doctor.
• Do not share your drugs with others and do not take anyone else's drugs.
• Keep a list of all your drugs (prescription, natural products, vitamins, OTC) with you. Give this list to your doctor.
• Talk with the doctor before starting any new drug, including prescription or OTC, natural products, or vitamins.
• Some drugs may have another patient information leaflet. Check with your pharmacist. If you have any questions about HC DermaPax, please talk with your doctor, nurse, pharmacist, or other health care provider.
• If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.

This information should not be used to decide whether or not to take this medicine or any other medicine. Only the healthcare provider has the knowledge and training to decide which medicines are right for a specific patient. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about HC DermaPax. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to this medicine. This information is not specific medical advice and does not replace information you receive from the healthcare provider. You must talk with the healthcare provider for complete information about the risks and benefits of using HC DermaPax (hydrocortisone/diphenhydramine spray).

Review Date: October 4, 2017

WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:

• Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
• Very bad skin irritation.

Applies to diphenhydramine / hydrocortisone topical: topical spray

Dermatologic

Dermatologic side effects including local irritation have been reported to occur very rarely.[Ref]

Some side effects of HC-Derma-Pax may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

There are no data on the excretion of diphenhydramine-hydrocortisone topical into human milk. Systemic diphenhydramine is excreted into human milk. Systemic diphenhydramine may also inhibit lactation. The manufacturer of systemic diphenhydramine recommends that due to the potential for serious adverse reactions in nursing infants, a decision should be made to discontinue nursing or discontinue the drug, taking into account the importance of the drug to the mother. There are no data on the excretion of hydrocortisone into human milk. Some corticosteroids are excreted into human milk in small amounts. The manufacturer of systemic hydrocortisone recommends against the use of pharmacologic doses of hydrocortisone by nursing women.