DIPHENHYDRAMINE HCI AND ZINC ACETATE- itch relief continuous spray aerosol, spray

Diphenhydramine HCI and Zinc Acetate by

Drug Labeling and Warnings

Diphenhydramine HCI and Zinc Acetate by is a Otc medication manufactured, distributed, or labeled by Foodhold USA, Premier Brands of America Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredients

Diphenhydramine HCI 2.0%

Zinc Acetate 0.1%

Purpose

External Analgesic

Skin Protectant

Uses

for the temporary relief of pain and itching associated with:

• minor burns
• sunburn
• minor cuts
• scrapes
• insect bites
• minor skin irritations
• 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.

Flammable:

Keep away from fire or flame. Do not puncture or incinerate. Contents under pressure. Do not store at temperatures above 120ºF. Intentional misuse by deliberately concentrating and inhaling contents can be harmful or fatal.

Do not use

• on lare 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

When using this product

• avoid contact with eyes

Stop use and ask doctor if

• condition worsens
• symptoms last 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 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

store between 20º to 25ºC (68º to 77ºF)

Inactive Ingredients

aloe barbadensis leaf juice, glycerin, purified water, SD alcohol 40-B, tromethamine

Questions?

Call 1-866-964-0939

Principal Display Panel

CAREONE

Extra Strength Itch Relief Continuous Spray

Diphenhydramine Hydrochloride/

External Analgesic

Zinc Acetate / Skin Protectant

RELIEFS ITCHING FROM

INSECT BITES AND POISON

IVY, OAK & SUMAC

SOOTHES SUNBURN

AND MINOR BURNS & CUTS

NET WT 2.7 OZ (76g)

INGREDIENTS AND APPEARANCE

DIPHENHYDRAMINE HCI AND ZINC ACETATE 
itch relief continuous spray aerosol, spray

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 41520-090
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
BROMODIPHENHYDRAMINE HYDROCHLORIDE (UNII: 202J683U97) (BROMODIPHENHYDRAMINE - UNII:T032BI7727)	BROMODIPHENHYDRAMINE HYDROCHLORIDE	1.52 g  in 76 g
ZINC ACETATE (UNII: FM5526K07A) (ZINC CATION - UNII:13S1S8SF37)	ZINC ACETATE	0.076 g  in 76 g

Inactive Ingredients
Ingredient Name	Strength
GLYCERIN (UNII: PDC6A3C0OX)
TROMETHAMINE (UNII: 023C2WHX2V)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
WATER (UNII: 059QF0KO0R)
ALCOHOL (UNII: 3K9958V90M)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 41520-090-76	76 g in 1 CANISTER; Type 0: Not a Combination Product	03/04/2019

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part348	03/04/2019

Labeler - Foodhold USA (809183973)

Registrant - Premier Brands of America Inc. (063849780)