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Calamine by Dolgencorp, LLC

Dosage form: lotion
Ingredients: FERRIC OXIDE RED .8kg in 100L, ZINC OXIDE .8kg in 100L
Labeler: Dolgencorp, LLC
NDC Code: 55910-063

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 ingredients
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 the 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

Visit us at: Rexall.com
or call 1-866-4REXALL

DISTRIBUTED BY DOLGENCORP, LLC
100 MISSION RIDGE
GOODLETTSVILLE, TN 37072 USA

Since 1903
REXALL

Calamine
Lotion
Calamine topical Suspension USP
• Poison ivy, oak and sumac drying lotion
• Skin protectant

6 FL OZ (177 mL)

CALAMINE  
ferric oxide red lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55910-063
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
FERRIC OXIDE RED (FERRIC OXIDE RED) FERRIC OXIDE RED.8 kg  in 100 L
ZINC OXIDE (ZINC OXIDE) ZINC OXIDE.8 kg  in 100 L
Inactive Ingredients
Ingredient NameStrength
CALCIUM HYDROXIDE 
GLYCERIN 
Packaging
#Item CodePackage Description
1NDC:55910-063-30.177 L in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34604/13/2009
Labeler - Dolgencorp, LLC (068331990)
Registrant - Vi Jon (790752542)
Establishment
NameAddressID/FEIOperations
Vi Jon790752542manufacture

Revised: 10/2010
 
Dolgencorp, 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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