Otc - Purpose
| Active ingredients | Purpose |
|---|---|
| Diphenhydramine hydrochloride 2% | Topical analgesic |
| Zinc acetate 0.1% | Skin protectant |
Diphenhydramine Hydrochloride And Zinc Acetate Cream
FDA Label NDC 51672-2089
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Sun Pharmaceutical Industries, Inc. for the product Diphenhydramine Hydrochloride And Zinc Acetate (NDC 51672-2089). 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 otc - purpose, uses, warnings, otc - do not use, otc - ask doctor, otc - when using, otc - stop use, otc - keep out of reach of children, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Uses
- temporarily relieves pain and itching associated with:
- insect bites
- minor burns
- sunburn
- minor skin irritations
- minor cuts
- scrapes
- rashes due to poison ivy, poison oak, and poison sumac
- dries the oozing and weeping of poison ivy, poison oak, and poison sumac
Warnings
For external use only
Otc - Do Not Use
Do not use
- on large areas of the body
- with any other product containing diphenhydramine, even one taken by mouth
Otc - Ask Doctor
Ask a doctor before use
- on chicken pox
- on measles
Otc - When Using
When using this product
- avoid contact with eyes
Otc - Stop Use
Stop use and ask a doctor if
- condition worsens or does not improve within 7 days
- symptoms persist for more than 7 days or clear up and occur again within a few days
Otc - Keep Out Of Reach Of Children
Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.
Directions
- do not use more often 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: ask a doctor
Other Information
- To open: unscrew cap, use pointed end of cap to puncture seal.
- store at 20° to 25°C (68° to 77°F)
- see carton or tube crimp for lot number and expiration date
Inactive Ingredients
cetyl alcohol, glyceryl stearate, glyceryl stearate/PEG-100 stearate, methylparaben, propylene glycol, propylparaben and purified water
Questions?
Call 1-866-923-4914
Principal Display Panel - 28.4 G Tube Carton
Extra Strength
Anti-Itch Cream
Diphenhydramine Hydrochloride 2%
and Zinc Acetate 0.1%
Topical Analgesic • Skin Protectant
NET WT 1 oz (28.4 g)
Principal Display Panel (28.4 g Tube Carton)
* Please review the disclaimer below.
