CALAMINE - ferric oxide red lotion 
Perrigo Direct, Inc.

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Calamine Lotion
063.001/063AA

Active ingredients

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 - 86⁰F

Inactive ingredients

bentonite magma, calcium hydroxide, glycerin, purified water

Distributed by: Perrigo Direct, Inc.

Peachtree City, GA 30269

www.PerrigoDirect.com

1-888-593-0593

GoodSense® is a registered trademark of L. Perrigo Company.

Principal Panel Display

GOODSENSE

NDC 75981-063-30

Calamine Lotion

Calamine Topical Suspension USP

Skin Protectant

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:75981-063
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
FERRIC OXIDE RED (UNII: 1K09F3G675) (FERRIC OXIDE RED - UNII:1K09F3G675) FERRIC OXIDE RED8 mg  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:75981-063-30177 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product09/15/1992
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM01609/15/1992
Labeler - Perrigo Direct, Inc. (076059836)
Registrant - Vi-Jon, LLC (088520668)
Establishment
NameAddressID/FEIBusiness Operations
Vi-Jon, LLC790752542manufacture(75981-063)
Establishment
NameAddressID/FEIBusiness Operations
Vi-Jon, LLC088520668manufacture(75981-063)

Revised: 10/2023
Document Id: b1476ee2-5437-40b4-9954-6b0ef27a3547
Set id: 256bd1d4-fd50-408f-9aee-84f218bb4971
Version: 6
Effective Time: 20231016
 
Perrigo Direct, Inc.