EFFECTIVE ITCH RELIEF- diphenhydramine hci, zinc acetate spray 
TopCo

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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Drug Facts

Active ingredients

Diphenhydramine HCl 2.0%

Zinc Acetate 0.10%

Purpose

Topical analgesic

Skin protectant

Uses

Temporarily relieves pain and itching associated with:

Warnings

For external use only.

Flammable - Do not use while smoking or near heat or flame ​​​​

Do not use

Stop use and ask a doctor if

When using this product

keep out of eyes
use only as directed.
do not puncture or incinerate. Contents under pressure. Do not store at temperatures above 120F

Keep out of reach of children.

If swallowed, get help or contact a Poison Control Center right away.

Directions

Inactive ingredients

Alcohol Denat.
Glycerin
PVP
Tromethamine
Water

image description

EFFECTIVE ITCH RELIEF 
diphenhydramine hci, zinc acetate spray
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:36800-739
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DIPHENHYDRAMINE HYDROCHLORIDE (UNII: TC2D6JAD40) (DIPHENHYDRAMINE - UNII:8GTS82S83M) DIPHENHYDRAMINE HYDROCHLORIDE2.0 g  in 100 g
ZINC ACETATE (UNII: FM5526K07A) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION.10 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
ALCOHOL (UNII: 3K9958V90M)  
GLYCERIN (UNII: PDC6A3C0OX)  
POVIDONE (UNII: FZ989GH94E)  
WATER (UNII: 059QF0KO0R)  
TROMETHAMINE (UNII: 023C2WHX2V)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:36800-739-0385 g in 1 CAN; Type 0: Not a Combination Product01/22/2013
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34801/22/2013
Labeler - TopCo (006935977)
Registrant - Product Quest Mfg, LLC (927768135)
Establishment
NameAddressID/FEIBusiness Operations
Product Quest Mfg, LLC927768135manufacture(36800-739) , label(36800-739)

Revised: 7/2018
Document Id: 8a8749cd-b880-4f4d-ae1b-a1f7fcf38210
Set id: 66759e41-bcfb-4eff-9409-928acf361ba6
Version: 1
Effective Time: 20180724
 
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