DIPHENHYDRAMINE HCI AND ZINC ACETATE- itch relief continuous spray aerosol, spray 
Foodhold USA

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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CareOne Extra Strength Itch Relief Continuous Spray

Active Ingredients

Diphenhydramine HCI 2.0%

Zinc Acetate 0.1%

Purpose

External Analgesic

Skin Protectant

Uses

for the temporary relief of pain and itching associated with:

Warnings

For external use only.

Flammable:

Keep away from fire or flame. Do not puncture or incinerate. Contents under pressure. Do not store at temperatures above 120ºF. Intentional misuse by deliberately concentrating and inhaling contents can be harmful or fatal.

Do not use

  • on lare areas of the body
  • with any other product containing diphenhydramine, even one taken by mouth

Ask a doctor before use

  • on chicken pox
  • on measles

When using this product

  • avoid contact with eyes

Stop use and ask doctor if

  • condition worsens
  • symptoms last more than 7 days or clear up and occur again within a few days

Keep out of the reach of children.

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

Directions

Other Information

store between 20º to 25ºC (68º to 77ºF)

Inactive Ingredients

aloe barbadensis leaf juice, glycerin, purified water, SD alcohol 40-B, tromethamine

Questions?

Call 1-866-964-0939

Principal Display Panel

CAREONE

Extra Strength Itch Relief Continuous Spray

Diphenhydramine Hydrochloride/

External Analgesic

Zinc Acetate / Skin Protectant

RELIEFS ITCHING FROM

INSECT BITES AND POISON

IVY, OAK & SUMAC

SOOTHES SUNBURN

AND MINOR BURNS & CUTS

NET WT 2.7 OZ (76g)

Careone Itch Relief Continuous Spray

DIPHENHYDRAMINE HCI AND ZINC ACETATE 
itch relief continuous spray aerosol, spray
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:41520-090
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BROMODIPHENHYDRAMINE HYDROCHLORIDE (UNII: 202J683U97) (BROMODIPHENHYDRAMINE - UNII:T032BI7727) BROMODIPHENHYDRAMINE HYDROCHLORIDE1.52 g  in 76 g
ZINC ACETATE (UNII: FM5526K07A) (ZINC CATION - UNII:13S1S8SF37) ZINC ACETATE0.076 g  in 76 g
Inactive Ingredients
Ingredient NameStrength
GLYCERIN (UNII: PDC6A3C0OX)  
TROMETHAMINE (UNII: 023C2WHX2V)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
WATER (UNII: 059QF0KO0R)  
ALCOHOL (UNII: 3K9958V90M)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:41520-090-7676 g in 1 CANISTER; Type 0: Not a Combination Product03/04/2019
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34803/04/2019
Labeler - Foodhold USA (809183973)
Registrant - Premier Brands of America Inc. (063849780)

Revised: 1/2019
Document Id: 80ad4aca-9fba-adeb-e053-2991aa0adf94
Set id: 80ad4aca-9fb9-adeb-e053-2991aa0adf94
Version: 1
Effective Time: 20190130
 
Foodhold USA