CALAMINE- ferric oxide red lotion 
Major Pharmaceuticals

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Major 063.001/063AA
Calamine Lotion

Active ingredients

Calamine 8%
Zinc oxide 8%

Purpose

Skin Protectant

Use

dries the oozing and weeping of poison:

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

Questions?

1-888-593-0593

Adverse reactions

Distributed By:

MAJOR ®PHARMACEUTICALS

Indianapolis, IN 46268

(800) 616-2471

www.major-rugby.com

Rev. 03/25 M-97 Re-order No. 014283

principal display panel

NDC 0904-2533-21

MAJOR ®

Calamine Lotion

Calamine Topical Suspension USP

Calamine 8%, Zinc Oxide 8%

Skin Protectant

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

Shake well before using

6 FL OZ (177 mL)

image description

CALAMINE 
ferric oxide red lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0904-2533
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:0904-2533-21177 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product01/07/2013
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM01601/07/2013
Labeler - Major Pharmaceuticals (191427277)
Registrant - Nice-Pak Products, LLC (119091520)
Establishment
NameAddressID/FEIBusiness Operations
Nice-Pak Products, LLC119091514manufacture(0904-2533)

Revised: 2/2026
Document Id: 4a057dbb-483c-a4b4-e063-6394a90aa36a
Set id: c25be68d-834a-4959-8d47-01ec789406ba
Version: 15
Effective Time: 20260204
 
Major Pharmaceuticals