CALAMINE- ferric oxide red lotion 
Topco Associates 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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Top Care 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?

1888-423-0139

DISTRIBUTED BY TOPCO ASSOCIATES LLC

ELK GROVE VILLAGE, IL 60007

TOPCO VIJA0622 QUESTIONS? 1-888-423-0139

1-888-423-0139

topcare@topco.com www.topcarebrand.com

Visit here for more information:

http://topbrnds.com/4901jk

QUALITY GUARANTEED

principal display panel

NDC 36800-063-30

TopCare health

Calamine Lotion USP

CALAMINE TOPICAL SUSPENSION USP

SKIN PROTECTANT

Drying Lotion for:

6 FL OZ (177 mL)

image description

CALAMINE 
ferric oxide red lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:36800-063
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:36800-063-30177 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product09/15/1991
2NDC:36800-063-26237 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product09/15/199105/28/2021
3NDC:36800-063-34237 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product09/15/199105/28/2021
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34709/15/1991
Labeler - Topco Associates LLC (006935977)
Registrant - Vi Jon, LLC (790752542)
Establishment
NameAddressID/FEIBusiness Operations
Vi Jon, LLC790752542manufacture(36800-063)
Establishment
NameAddressID/FEIBusiness Operations
Vi Jon, LLC088520668manufacture(36800-063)

Revised: 8/2022
Document Id: aabb3049-e037-4888-9224-19e4d979d4d1
Set id: 2b32e720-ac71-4d60-bc06-e28a00f8a450
Version: 18
Effective Time: 20220808
 
Topco Associates LLC