CALAMINE - ferric oxide red lotion 
FOODHOLD U.S.A. LLC

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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Care One 063.001 063AA

Active ingredents

Calamine 8%
Zinc oxide 8%

Purpose

Skin Protectant

Use

dries the oozing and weeping of poison:•ivy • oak • sumac

Warnings

For external use only

When using this product

Do not get into eyes

Stop use and ask a doctor if

  • 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

Directions

• shake well before using • apply as needed

Other information

store at 59⁰ - 86⁰ F

Inactive ingredients

bentonite magma, calcium hydroxide, glycerin, purified water

Adverse Reaction Section

DISTRIBUTED BY FOODHOLD U.S.A., LLC

LANDOVER, MD 20785

2016 S&S BRANDS LLC

QUALITY GUARANTEED OR YOUR MONEY BACK

063.000/063AA

principal display panel

CAREONE

Calamine

Lotion

CALAMINE TOPICAL

SUSPENSION USP

Skin Protectant

CALAMINE 8%

ZINC OXIDE 8%

POISON IVY, OAK, SUMACK

DRYING LOTION

OUR PHARMACISTS RECOMMEND

6 FL OZ (177 mL)

image description

CALAMINE  
ferric oxide red lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:41520-063
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
FERRIC OXIDE RED (UNII: 1K09F3G675) (FERRIC OXIDE RED - UNII:1K09F3G675) FERRIC OXIDE RED8 g  in 1 mL
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE8 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
BENTONITE (UNII: A3N5ZCN45C)  
CALCIUM HYDROXIDE (UNII: PF5DZW74VN)  
GLYCERIN (UNII: PDC6A3C0OX)  
WATER (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:41520-063-30177 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product02/06/201309/18/2023
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34702/06/201309/18/2023
Labeler - FOODHOLD U.S.A. LLC (809183973)
Registrant - Vi Jon (790752542)
Establishment
NameAddressID/FEIBusiness Operations
Vi Jon088520668manufacture(41520-063)

Revised: 9/2023
 
FOODHOLD U.S.A. LLC