Quality Choice Itch Relief (Diphenhydramine Hcl, Zinc Acetate) Spray [Chain Drug Marketing Association] -

QUALITY CHOICE ITCH RELIEF (DIPHENHYDRAMINE HCL, ZINC ACETATE) SPRAY [CHAIN DRUG MARKETING ASSOCIATION]
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NDC	63868-952-02
Set ID	8735b298-83f3-0b5d-e053-2a91aa0a8292
Category	HUMAN OTC DRUG LABEL
Packager	Chain Drug Marketing Association
Generic Name
Product Class
Product Number
Application Number	PART348

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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

Quality Choice

Compare to the active ingredients in BENADRYL® ITCH RELIEF SPRAY

Extra Strength Itch Relief Spray

Skin protectant Topical analgesic

Diphenhydramine hydrochloride 2% Zinc acetate 0.1%

For Skin Use Only

INGREDIENTS AND APPEARANCE

QUALITY CHOICE ITCH RELIEF
diphenhydramine hcl, zinc acetate spray

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
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

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:63868-952-02	59 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product	04/14/2014

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part348	04/14/2014

Labeler - Chain Drug Marketing Association (011920774)

Registrant - Weeks & LEO, Inc. (005290028)

Name	Address	ID/FEI	Business Operations
Establishment
Weeks & Leo		005290028	manufacture(63868-952)

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Medic