ITCH RELIEF- diphenhydramine hcl, zinc acetate spray
American Sales Company

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Itch Relief Spray

Active ingredients

Diphenhydramine HCl 2%
Zinc Acetate 0.1%

Purpose

External analgesic
Skin protectant

Uses

•for the temporary relief of pain and itching associated with minor skin irritations
•dries the oozing and weeping of poison: iv, oak, sumac

Warnings

For external use only

Flammable. Keep away from fire of flame.

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 or measles

When using this product

do not get into eyes

Stop use and ask a doctor if

condition worsens or 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 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 at 20⁰ - 25⁰C (68⁰ - 77⁰F)

Inactive ingredients

alcohol, glycerin, povidone, purified water, tris (hydroxymethyl)aminomethane

Not manufactured or distributed by Johnson + Johnson Consumer Products Company, distributor of Benadryl Spray*

Distributed by: American Sales Company
4201 Walden Avenue, Lancaster, NY 14086
S+S BRANDS. INC www.Care1.info
Quality guaranteed or your money back

principal display panel

TEAR HERE
Compare to Active Ingredients in Benadryl Spray*
CAREONE ITCH RELIEF SPRAY
SKIN PROTECTANT
TOPICAL ANALGESIC
Relieves itching due to insect bites poison oak or ivy, or other minor skin irritations
2 FL OZ (59 mL)

295.000/295AB

image description

ITCH RELIEF
diphenhydramine hcl, zinc acetate spray

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:41520-295
Route of Administration	TOPICAL

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

Ingredient Name	Strength
Inactive Ingredients
ALCOHOL (UNII: 3K9958V90M)
GLYCERIN (UNII: PDC6A3C0OX)
POVIDONE (UNII: FZ989GH94E)
WATER (UNII: 059QF0KO0R)
TROMETHAMINE (UNII: 023C2WHX2V)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:41520-295-16	0.059 L in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product	10/06/2011	09/20/2023

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part348	10/06/2011	09/20/2023

Labeler - American Sales Company (809183973)

Registrant - Vi-Jon (790752542)

Name	Address	ID/FEI	Business Operations
Establishment
Vi-Jon		790752542	manufacture(41520-295)

Revised: 9/2023

Document Id: 16fad921-8b3f-4880-8882-542aace93c95

Set id: 3fad67da-58ce-4f5f-b8c1-738d44656ce6

Version: 6

Effective Time: 20230920

American Sales Company