CALAMINE - ferric oxide red lotion 
DZB Brands, 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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Calamine Lotion

Active ingredient

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 - 86⁰F

Inactive ingredients

bentonite magma, calcium hydroxide, glycerin, purified water

Distributed by: DZA Brands, LLC

Salisbury, NC 28147/Scarborough, ME 04074

For product questions or concerns

contact us at 1-866-322-2439

Made in the USA with US and foreign components

principal display panel

NDC 55316-063-26

healthy

accents

calamine lotion

calamine topical suspension USP

skin protectant

Net 6 FL OZ (177mL)

image description

CALAMINE  
ferric oxide red lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55316-063
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)  
Product Characteristics
ColorwhiteScore    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:55316-063-26177 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product02/05/2008
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34702/05/2008
Labeler - DZB Brands, LLC (090322194)
Registrant - Vi-Jon, LLC (790752542)
Establishment
NameAddressID/FEIBusiness Operations
Vi-Jon, LLC790752542manufacture(55316-063)
Establishment
NameAddressID/FEIBusiness Operations
Vi-Jon, LLC088520668manufacture(55316-063)

Revised: 12/2022
Document Id: c157b5cb-59d7-4455-9624-4f20e3ca9e20
Set id: 8c1b0675-bbe9-42a4-80f1-3efff1d6346c
Version: 25
Effective Time: 20221208
 
DZB Brands, LLC