ITCH RELIEF- diphenhydramine hci, zinc acetate spray 
Care One

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

Other information Store at 20° to 25°C (68° to 77°F)

Questions? 1-877-846-9949

image description

ITCH RELIEF 
diphenhydramine hci, zinc acetate spray
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:41520-350
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:41520-350-0385 g in 1 CAN; Type 0: Not a Combination Product02/24/2015
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34802/24/2015
Labeler - Care One (809183973)
Registrant - Product Quest Mfg, LLC (927768135)
Establishment
NameAddressID/FEIBusiness Operations
Product Quest Mfg, LLC927768135manufacture(41520-350) , label(41520-350)

Revised: 8/2018
Document Id: 687657f8-a35c-4399-bc58-6341ca2c96a1
Set id: 7a44fceb-ef28-423e-9f9a-8ea512697550
Version: 1
Effective Time: 20180808
 
Care One