Active Ingredient
Diphenhydramine Hydrochloride 2%
Zinc Acetate 0.1%
Anti-itch Cream
FDA Label NDC 83324-039
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Chain Drug Marketing Association Inc. for the product Anti-itch Cream (NDC 83324-039). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding active ingredient, purpose, indications & usage, warnings, stop use and ask a doctor, keep out of the reach of children, directions, other information, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
Topical Analgesic
Skin Protectant
Indications & Usage
For the temporary relief from pain and itching associated with
- insect bites
- minor burns
- minor skin irritation
- rashes due to poison ivy, poison oak, and poison sumac
- dries the weeping and oozing of poison ivy, oak and sumac
Warnings
For External Use Only
Do not useon large areas of the body or with any other product containing diphenhydramine, even one taken by mouth
Ask a doctor before use on chicken pox or measles
When using this productavoid contact with eyes
Stop use and ask a doctor if
- Conditions worsen or do not improve within 7 days
- Symptoms persist for more than 7 days or clear up and occur again within a few days
Stop Use And Ask A Doctor
- Conditions worsen or do not improve within 7 days
- Symptoms persist for more than 7 days or clear up and occur again within a few days
Keep Out Of The Reach Of Children
If swallowed, get medical help or contact a Poison Control Center immediately
Directions
- Do not use more than directed
- Adults and children 2 years of age and older: apply to affected area not more than 3 to 4 times daily
- Children under 2 years of age: consult a doctor
Other Information
- Store at controlled room temperature 20°-25°C (68°-77°F)
- Close cap tightly after use
Questions?Call 1-800-935-2362
Inactive Ingredients
Aloe Vera (Aloe Barbadensis) leaf juice, Cetyl alcohol, Glyceryl monostearate, Methylparaben, Mineral Oil, Petrolatum, Polyoxyethylene lauryl ether, Propylene glycol, Propylparaben, Purified Water, Stearic acid
Distributed By
Distributed by CDMA Inc.
Novi, MI 48375
www.qualitychoice.com
Questions: 800-935-2362
This product is not manufactured or distributed by Johnson & Johnson Consumer Products Company owner of the registered trademark Benadryl.
* Please review the disclaimer below.
