CALAMINE- ferric oxide red lotion 
Major Pharmaceuticals

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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Major 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

Questions or comments?

(800) 616-2471

Adverse reactions

Distributed By:

MAJOR PHARMACEUTICALS

17177 N LAUREL PARK DRIVE, SUITE 233

Livonia, MI 48152

Re-Order No 014282  M-97

Rev. 10/16

principal display panel

NDC 0904-2533-21

MAJOR

Calamine

Lotion

Calamine Topical Suspension USP

Skin Protectant

Poison Ivy, Oak, Sumac

Drying Lotion

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 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: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 FINALpart34701/07/2013
Labeler - Major Pharmaceuticals (191427277)
Registrant - Vi-Jon, LLC (790752542)
Establishment
NameAddressID/FEIBusiness Operations
Vi-Jon, LLC790752542manufacture(0904-2533)
Establishment
NameAddressID/FEIBusiness Operations
Vi-Jon, LLC088520668manufacture(0904-2533)

Revised: 4/2022
Document Id: 8a532bb2-117d-4b42-a4a9-768af4e44e45
Set id: c25be68d-834a-4959-8d47-01ec789406ba
Version: 11
Effective Time: 20220405
 
Major Pharmaceuticals