WESTLAKE ITCH RELIEF- diphenhydramine hcl, zinc acetate spray

Westlake Itch Relief by

Drug Labeling and Warnings

Westlake Itch Relief by is a Otc medication manufactured, distributed, or labeled by Westlake HB Pharma LLC, Weeks & Leo Co., Inc., Weeks & Leo. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredient

Diphenhydramine hydrochloride 2% Topical analgesic

Zinc acetate 0.1% Skin protectant

Uses

for

temporary relieves pain and itching due to:

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

oak

sumac

Directions

do not use more often than directed

adults and children 2 years and older: apply to affected area not more than 3 to 4 times daily

children under 2 years: ask a doctor

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 doctor Before use

on chicken pox

on measles

When using this product

do not get into eyes

Stop Use and ask physician

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.

Warning

for external use only

Purposes

Itch relief

Inactive Ingredients

Purified Water, Glycerin, SD Alcohol, Povidone, Povidonee (K-30), Trolamine

Prinicpal dispaly panel

Diphenhydramine hydrochloride 2%

Topical analgesic

Zinc acetate 0.1% Skin protectant

Relieves Itch and Pain associated with insects bites & rashes due to posinon ivy Oak& sumac

INGREDIENTS AND APPEARANCE

WESTLAKE ITCH RELIEF 
diphenhydramine hcl, zinc acetate spray

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 82895-715
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ZINC ACETATE (UNII: FM5526K07A) (ZINC CATION - UNII:13S1S8SF37)	ZINC ACETATE	0.1 g  in 100 mL
DIPHENHYDRAMINE HYDROCHLORIDE (UNII: TC2D6JAD40) (DIPHENHYDRAMINE - UNII:8GTS82S83M)	DIPHENHYDRAMINE HYDROCHLORIDE	2 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
GLYCERIN (UNII: PDC6A3C0OX)
ALCOHOL (UNII: 3K9958V90M)
POVIDONE K30 (UNII: U725QWY32X)
TROLAMINE (UNII: 9O3K93S3TK)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 82895-715-60	59 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product	10/01/2023

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M017	10/01/2023

Labeler - Westlake HB Pharma LLC (081176855)

Registrant - Weeks & Leo Co., Inc. (005290028)

Establishment
Name	Address	ID/FEI	Business Operations
Weeks & Leo		005290028	manufacture(82895-715)