DIPHENHYDRAMINE HCL AND ZINC ACETATE- extra strength itch relief continuous spray aerosol, spray

Diphenhydramine HCl and Zinc Acetate by

Drug Labeling and Warnings

Diphenhydramine HCl and Zinc Acetate by is a Otc medication manufactured, distributed, or labeled by Topco Associates LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredients

Diphenhydramine HCL 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 120 ºF

Intentional misuseby deliberately concentrating and inhaling contents can be harmful or fatal.

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

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 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 20° to 25° C (68° to 77°F)

Inactive ingredients

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

Questions?

Call 1-888-423-0139

Principal Display Panel

TopCare health

EXTRA STRENGTH

Itch Relief Continous Spray

DIPHENHYDRAMINE HYDROCHLORIDE 2%

EXTERNAL ANALGESIC

ZINC ACETATE 0.1%

SKIN PROTECTANT

• Relieves Itching from Insect Bites, Poison Ivy, Oak & Sumac
• Soothes Sunburn & Minor Burns & Cuts

NET WT 2.7 OZ (76g)

INGREDIENTS AND APPEARANCE

DIPHENHYDRAMINE HCL AND ZINC ACETATE 
extra strength itch relief continuous spray aerosol, spray

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 36800-126
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
DIPHENHYDRAMINE HYDROCHLORIDE (UNII: TC2D6JAD40) (DIPHENHYDRAMINE - UNII:8GTS82S83M)	DIPHENHYDRAMINE HYDROCHLORIDE	1.5 g  in 76 g
ZINC ACETATE (UNII: FM5526K07A) (ZINC CATION - UNII:13S1S8SF37)	ZINC ACETATE	0.075 g  in 76 g

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

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 36800-126-76	76 g in 1 CANISTER; Type 0: Not a Combination Product	03/05/2019

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part348	03/05/2019

Labeler - Topco Associates LLC (006935977)