Active Ingredient
Diphenhydramine Hydrochloride 2%
Zinc Acetate 0.1%
Itch Stopping Cream
FDA Label NDC 69396-150
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Trifecta Pharmaceuticals Usa, Llc. for the product Itch Stopping Cream (NDC 69396-150). 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, do not use, when using this product, stop use and ask a doctor if, keep out of the reach of children, 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
Temporarily relieves pain and itching associated with
- insect bites
- minor burns
- minor skin irritation
- sunburn
- scrapes
- rashes due to poison ivy, poison oak, and poison sumac
- dries the weeping and oozing of poison ivy, poison oak and poison sumac
Warnings
For External Use Only
Do Not Use
Do Not Use on large areas of the body or with any other product containing diphenhydramine, even one taken by mouth.
When Using This Product
When Using this Product avoid contact with Eyes
Stop Use And Ask A Doctor If
Stop Use and Ask a Doctor if
- Conditions worsen or do not improve within 7 days
- Symptoms presist 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
Ask A Doctor Before Use
Ask a doctor before use on chicken pox or measles
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
Inactive Ingredients
Aloe Barbadensis leaf juice, Cetyl alcohol, Glyceryl monostearate, Methylparaben, Mineral Oil, Petrolatum, Polyoxyethylene lauryl ether, Propylene glycol, Propylparaben, Purified Water, Stearic acid
Distributed By:
Proudly Distributed by Associated Wholesale Grocers Inc.
Kansas City, KS. 66106 USA
Questions Call: 1-877-753-3935
Monday-Friday 9AM-5PM EST
This product is not manufactured or distributed by Johnson & Johnson Consumer Inc., owner of the registered trademark Extra Strength Benadryl® Itch Stopping Cream.
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