Active Ingredient
Diphenhydramine Hydrochloride 2%
Zinc Acetate 0.1%
Itch Relief Cream
FDA Label NDC 68016-163
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Pharmacy Value Alliance Llc for the product Itch Relief Cream (NDC 68016-163). 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, uses, warnings, stop use and ask a doctor if, 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
Uses
For the temporary relief from pain and itcing assciated with:
- insect bites
- minor burns
- sunburn
- minor skin irritation
- minor cuts
- rashes due to poison ivy, poison oak, and poison sumac
- dries 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 if you have 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
Keep Out Of The Reach Of Children.
If swallowed, get medical help or contact 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
Inactive Ingredients
Aloe Vera (Aloe Barbadensis), leaf juice, Cetyl alcohol, Glyceryl monostearate, Methylparaben, Mineral Pil, Petrolatum, Polyoxyethylene, lauryl ether, Propylene glycol, Propylparaben, Purified Water, Stearic acid
Itch Relief Cream Antihistamine Topical Analgesic Skin Protectant
Temporarily relieves the itching and pain associated with:
- insect bites
- allergic itch
- skin irritations
Distributed By:
Pharmacy Value Alliance, LLC.
407 East Lancaster Avenue
Wayne, PA. 19087
www.emersongroup.com
Product of PRC
* Please review the disclaimer below.
