CAREONE ALLERGY- diphenhydramine hydrochloride, zinc acetate cream

CAREONE ALLERGY by

Drug Labeling and Warnings

CAREONE ALLERGY by is a Otc medication manufactured, distributed, or labeled by AMERICAN SALES COMPANY. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active Ingredients                                                                          Purpose

Diphenhydramine Hydrochloride 2% ...............................................Topical analgesic

Zinc acetate, 0.1% .......................................................................Skin Protectant

PURPOSE

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

Warnings

For external use only

DO NOT USE

Do not use on large area of the body or with any other product containing diphenhydramine, even one taken by mouth.

ASK DOCTOR

Ask a doctor before use

on chicken pox or on measles.

WHEN USING

When using this product

avoid contact with the eyes.

STOP USE

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.

PREGNANCY OR BREAST FEEDING

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

KEEP OUT OF REACH OF CHILDREN

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

INDICATIONS & USAGE

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

STORAGE AND HANDLING

Other information

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

INACTIVE INGREDIENT

Inactive ingredients

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

DOSAGE & ADMINISTRATION

DISTRIBUTED BY

FOODHOLD U.S.A., LLC

LANDOVER, MD 20785

PRODUCT OF SOUTH KOREA

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

CAREONE ALLERGY 
diphenhydramine hydrochloride, zinc acetate cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 41520-314
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
DIPHENHYDRAMINE HYDROCHLORIDE (UNII: TC2D6JAD40) (DIPHENHYDRAMINE - UNII:8GTS82S83M)	DIPHENHYDRAMINE HYDROCHLORIDE	20 mg  in 1 g
ZINC ACETATE (UNII: FM5526K07A) (ZINC CATION - UNII:13S1S8SF37)	ZINC CATION	1 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 41520-314-28	1 in 1 CARTON	09/14/2016
1		28 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part348	03/01/2012

Labeler - AMERICAN SALES COMPANY (809183973)