CALAMINE - ferric oxide red lotion 
Wakefern Food Corp

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.

----------

Shop Rite 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

Keep out of reach of children

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

Directions

Other information

store at 59⁰ - 86⁰ F

Inactive ingredients

bentonite magma, calcium hydroxide, glycerin, purified water

Adverse Reaction Section

DISTRIBUTED BY

WAKEFERN FOOD CORP.

5000 RIVERSIDE DRIVE

KEASBEY, NJ 08832

principal display panel

ShopRite

SKIN PROTECTANT

CALAMINE

LOTION

CALAMINE TOPICAL SUSPENSION U.S.P.

POISON IVY, OAK, SUMAC DRYING LOTION

6 FL OZ (177 mL)

image description

CALAMINE  
ferric oxide red lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:41190-063
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
FERRIC OXIDE RED (UNII: 1K09F3G675) (FERRIC OXIDE RED - UNII:1K09F3G675) FERRIC OXIDE RED80 mg  in 1 mL
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE80 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:41190-063-30177 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product07/15/1989
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34707/15/1989
Labeler - Wakefern Food Corp (069722418)
Registrant - Vi Jon, LLC (790752542)
Establishment
NameAddressID/FEIBusiness Operations
Vi Jon, LLC790752542manufacture(41190-063)
Establishment
NameAddressID/FEIBusiness Operations
Vi Jon, LLC088520668manufacture(41190-063)

Revised: 4/2022
Document Id: fc0218d7-2776-450e-a694-556d637050e3
Set id: 75d27726-68b5-4b2a-b374-03ae059ee5fc
Version: 13
Effective Time: 20220407
 
Wakefern Food Corp