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Calamine by Topco Associates LLC

Medically reviewed on April 3, 2018

Dosage form: lotion
Ingredients: FERRIC OXIDE RED 8g in 1mL, ZINC OXIDE 8mg in 1mL
Labeler: Topco Associates LLC
NDC Code: 36800-063

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.

Drug Facts

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
  • condition worsens
  • symptoms last more than 7 days or clear up and occur again within a few days

Keep out of reach of children

If swallowed, get medical help or contact a Poison Control Center right away

Directions
  • shake well before using
  • apply as needed

Other information

store at 59⁰ - 86⁰ F

Inactive ingredients

bentonite magma, calcium hydroxide, glycerin, purified water

Adverse Reaction Section

DIST.BY TOPCO ASSOCIATES LLC

ELK GROVE VILLAGE, IL 60007

1-888-423-0139  TOPCO VIJ 712

topcare@topco.com

063.001/063AA

Principal display panel

NDC 36800-063-30

TOPCARE

Calamine

Lotion

CALAMINE TOPICAL

SUSPENSION USP

SKIN PROTECTANT

POISON IVY, OAK SUMAC DRYING LOTION

6 FL OZ (177 mL)

CALAMINE 
ferric oxide red lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:36800-063
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
FERRIC OXIDE RED (FERRIC OXIDE RED) FERRIC OXIDE RED8 g  in 1 mL
ZINC OXIDE (ZINC OXIDE) ZINC OXIDE8 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
BENTONITE 
CALCIUM HYDROXIDE 
GLYCERIN 
WATER 
Packaging
#Item CodePackage Description
1NDC:36800-063-30177 mL in 1 BOTTLE, PLASTIC
2NDC:36800-063-26237 mL in 1 BOTTLE, PLASTIC
3NDC:36800-063-34237 mL in 1 BOTTLE, PLASTIC
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 (790752542)
Establishment
NameAddressID/FEIOperations
Vi Jon790752542manufacture(36800-063)

 
Topco Associates LLC

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Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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