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Calamine by DZB Brands, LLC

Dosage form: lotion
Ingredients: FERRIC OXIDE RED .8kg in 100L, ZINC OXIDE .8kg in 100L
Labeler: DZB Brands, LLC
NDC Code: 55316-063

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 withing 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 - 86⁰F

Inactive ingredients bentonite magma, calcium hydroxide, glycerin, purified water

Distributed by: DZA Brands, LLC
2110 Executive Drive
Salisbury, NC 28147

For product questions or concerns
contact us at 1-866-322-2439
Please include the UPC number and
code from package

NDC 55316-063-26
healthy
accents
calamine topical suspension USP
calamine lotin
skin protectant
poison ivy, oak + sumac
drying lotion
4 FL OZ (118 mL)

CALAMINE  
ferric oxide red lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55316-063
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:55316-063-26.118 L in 1 BOTTLE, PLASTIC
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34602/05/2008
Labeler - DZB Brands, LLC (090322194)
Registrant - Vi-Jon (790752542)
Establishment
NameAddressID/FEIOperations
Vi-Jon790752542manufacture

 
DZB Brands, LLC

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Medically reviewed on Jan 1, 2018

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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