FDA Label for Anti-itch Cream
View Indications, Usage & Precautions
Anti-itch Cream Product Label
The following document was submitted to the FDA by the labeler of this product Front Pharmaceutical Plc. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.
Active Ingredients
Diphenhydramine hydrochloride 2%
Zinc Acetate 0.1%
Purpose
Topical Analgesic
Skin Protectant
Use
for temporary relief from pain and itching associated with insect bites, sunburn, and minor skin irritations. Dries the oozing and weeping of poison:
- ivy
- oak
- sumac
Warnings
For external use only
Do Not Use
- over large areas of the body
- with any other product containing diphenhydramine, including those taken orally
When Using This Product
- avoid contact with eyes
Ask A Doctor Before Use
- on chicken pox
- on measles
Stop Use And Ask A Doctor If
- symptoms last for more than 7 days
- the condition gets worse
- symptoms clear up and then occur again within a few days
Keep Out Of Reach Of Children
If swallowed, get medical help or contact a Poison Control Center right away.
Directions
- adults and children 2 years of age and older: apply to affected area not more than 3 to 4 times per day.
- children under 2 years of age: ask a doctor before use
Inactive Ingredients
cetyl alcohol, glyceryl monostearate, methylparaben, mineral oil, petrolatum, polyoxyethylene lauryl ether, propylene glycol, propylparaben, purified water, stearic acid, stearyl alcohol
Questions
1-800-639-3803 Weekdays 9 AM to 4 PM EST
Other Information
- store at room temperature 59 degrees - 77 degrees F (15 degrees - 25 degrees C).
- tamper-evident: do not use if foil seal is broken or missing.
Package Label.Principal Display Panel
Extra Strength
Anti-Itch Cream
Topical Analgesic and Skin Protectant Cream
Net Wt 1 oz (28 g)
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