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Drug Facts
Shopko Anti-itch Cream
FDA Label NDC 37012-089
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Shopko Stores Operating Co., Llc for the product Shopko Anti-itch (NDC 37012-089). 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 other, otc - purpose, uses, warnings, do not use, ask a doctor before use, otc - when using, stop use and ask a doctor if, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Purpose
| Active ingredients | Purpose |
|---|---|
| Diphenhydramine hydrochloride 2% | Topical analgesic |
| Zinc acetate 0.1% | Skin protectant |
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
Do Not Use
- on large areas of the body
- with any other product containing diphenhydramine, even one taken by mouth
Ask A Doctor Before Use
- on chicken pox
- on measles
Otc - When Using
When using this product avoid contact with eyes
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
SHOPKO®
NDC 37012-089-02
Extra Strength
Anti-Itch Cream
Diphenhydramine hydrochloride 2% and Zinc acetate 0.1%
Antihistamine • Topical Analgesic • Skin Protectant
NET WT 1 OZ (28.4 g)
Principal Display Panel (28.4 g Tube Carton)
* Please review the disclaimer below.
