Active Ingredient
Diphenhydramine Hydrochloride 2%
Zinc Acetate 0.1%
Anti-itch Cream
FDA Label NDC 69396-025
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 Anti-itch Cream (NDC 69396-025). 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 use on 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 product avoid 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 1-888-296-9067
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:
Trifecta Pharmaceuticals USA, LLC.
101 NE Third Avenue, Suite 1500
Ft. Lauderdale, FL. 33301 USA
Product of PRC
www.trifecta-pharma.com
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