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Calamine by Major Pharmaceuticals

Medically reviewed on Mar 28, 2018

Dosage form: lotion
Ingredients: FERRIC OXIDE RED 8g in 1mL, ZINC OXIDE 8mg in 1mL
Labeler: Major Pharmaceuticals
NDC Code: 0904-2533

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

Questions or comments?

(800) 616-2471

Adverse reactions

Distributed By:

MAJOR PHARMACEUTICALS

17177 N LAUREL PARK DRIVE, SUITE 233

Livonia, MI 48152

Re-Order No 014282  M-97

Rev. 10/16

063.001/063AA

Principal Display Panel

NDC 0904-2533-21

MAJOR

Calamine

Lotion

Calamine Topical Suspension USP

Skin Protectant

Poison Ivy, Oak, Sumac

Drying Lotion

Shake well before using

6 FL OZ (177 mL)

CALAMINE 
ferric oxide red lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0904-2533
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:0904-2533-21177 mL in 1 BOTTLE, PLASTIC
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart34701/07/2013
Labeler - Major Pharmaceuticals (191427277)
Registrant - Vi-Jon, Inc (790752542)
Establishment
NameAddressID/FEIOperations
Vi-Jon, Inc790752542manufacture(0904-2533)

 
Major Pharmaceuticals

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Further information

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

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