Phos-Flur Gel

Frequent topical applications to the teeth with preparations having a relatively high fluoride content increase tooth resistance to acid dissolution and enhance penetration of the fluoride ion into tooth enamel.

Do not use in pediatric patients under age 6 years unless recommended by a dentist or physician.

Prolonged daily ingestion may result in various degrees of dental fluorosis in pediatric patients under age 6 years, especially in the areas with high fluoride concentration in drinking water. Use in pediatric patients under age 6 years requires special supervision to prevent repeated swallowing of gel. Use cautiously in patients with porcelain or ceramic restorations as per PRECAUTIONS below. Read directions carefully before using. Keep out of reach of infants and children.

1. American Dental Association, Council on Dental Therapeutics, Fluoride compounds, In: Accepted Dental Therapeutics, Ed. 40, Chicago, ADA, 405-407 (1984).
2. H.R. Englander et al., Clinical Anticaries Effect of Repeated Topical Sodium Fluoride Applications by Mouthpieces, JADA, 75, 638-644 (1967).
3. H.R. Englander et al., Residual Anticaries Effect of Repeated Topical Sodium Fluoride Applications by Mouthpieces, JADA, 78, 783-787 (1969).
4. H.R. Englander et al., Incremental Rates of Dental Caries After Repeated Topical Sodium Fluoride Applications in Children With Lifelong Consumption of Fluoridated Water, JADA 82, 354-358, (1971).
5. Hirschfield RE et al: Angle Orthod., 44 (3): 218-221, 1994.

Colgate Oral Pharmaceuticals, Inc.
a subsidiary of Colgate-Palmolive Company
New York, NY 10022 U.S.A.

Questions/Comments: 1-800-962-2345
www.colgateprofessional.com

P10001149
Rev. Apr. 2009

Colgate®

Phos•Flur®
Gel

Rx ONLY

1.1% Sodium Fluoride and
Acidulated Phosphate Gel

Helps Prevent Orthodontic Decalcification

MINT

NDC 0126-0131-66

NET WT. 1.8 OZ (51 g)

Applies to fluoride topical: dental cream, dental gel, dental paste, mouth/throat concentrate, mouth/throat liquid, mouth/throat paste, mouth/throat solution

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 upset stomach or throwing up.

Applies to fluoride topical: mucous membrane powder for reconstitution, mucous membrane solution, topical cream, topical gel, topical kit, topical paste, topical solution, topical swab

Hypersensitivity

Hypersensitivity side effects including allergic reactions have been reported.[Ref]

Oncologic

It has been shown that fluoride ion has potential to induce chromosome aberrations in cultured human and animal cells at doses much higher than those to which humans are exposed. In vivo data are conflicting.[Ref]

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