CAREONE ALLERGY- diphenhydramine hydrochloride, zinc acetate cream 
AMERICAN SALES COMPANY

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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CareOne Allergy Cream 2% 1 oz. 31359 (2019)

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 area of the body or with any other product containing diphenhydramine, even one taken by mouth.

Ask a doctor before use

on chicken pox or on measles.

When using this product

avoid contact with the eyes.

Stop use and ask a doctor if condition worsens or does not improve within 7 days, or symptoms persist for more than 7 days, or clear up and occur again within a few days.

If pregnant or breast-feeding, ask a health professional before use.

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

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, or as directed by a doctor
  • children under 2 years of age: consult a doctor

Other information

  • protect from excessive heat (40°C/104°F)

Inactive ingredients

cetyl alcohol, methylparaben, polyxoxyl 40 stearate, propylene glycol, propylparaben, purified water, stearyl alcohol

DISTRIBUTED BY

FOODHOLD U.S.A., LLC

LANDOVER, MD 20785

PRODUCT OF SOUTH KOREA

31359

CAREONE ALLERGY 
diphenhydramine hydrochloride, zinc acetate cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:41520-314
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DIPHENHYDRAMINE HYDROCHLORIDE (UNII: TC2D6JAD40) (DIPHENHYDRAMINE - UNII:8GTS82S83M) DIPHENHYDRAMINE HYDROCHLORIDE20 mg  in 1 g
ZINC ACETATE (UNII: FM5526K07A) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION1 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
CETYL ALCOHOL (UNII: 936JST6JCN)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
POLYOXYL 40 STEARATE (UNII: 13A4J4NH9I)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
PROPYLPARABEN (UNII: Z8IX2SC1OH)  
WATER (UNII: 059QF0KO0R)  
STEARYL ALCOHOL (UNII: 2KR89I4H1Y)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:41520-314-281 in 1 CARTON09/14/2016
128 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34803/01/201209/15/2021
Labeler - AMERICAN SALES COMPANY (809183973)

Revised: 11/2021
 
AMERICAN SALES COMPANY