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Calamine by Navarro Discount Pharmacies, LLC

Medically reviewed on May 7, 2018

Dosage form: lotion
Ingredients: ZINC OXIDE 80mg in 1mL, FERRIC OXIDE RED 80mg in 1mL, PRAMOXINE HYDROCHLORIDE 10mg in 1mL
Labeler: Navarro Discount Pharmacies, LLC
NDC Code: 59970-075

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%

Pramoxine HCl 1%

Purpose

Skin protectant

Topical analgesic

Uses

temporarily relieves pain and itching associated with:

  • rashes due to poison ivy, poison oac or poison sumac
  • insect bites
  • minor skin irritation
  • minor cuts

dries the oozing and weeping of poison ivy, poison oak and poison sumac

Warnings

For external use only.

When using this product

do not get into eyes

Stop use and ask a doctor if
  • condition worsens or does not improve within 7 days
  • symptoms persist for 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 use
  • adults and children 2 years of age and older: apply to affected area not more than 3 to 4 times daily
  • children under 2 years of age: ask a doctor

Other information
  • store at 20° to 25°C (68° to 77°F)

Inactive ingredients

SD alcohol 38-B, camphor, diazolidinyl urea, fragrance, hypromellose, methylparaben, polysorbate 80, propylene glycol, propylparaben, purified water, zanthan gum

Package Label

CALAMINE 
zinc oxide, ferric oxide red, pramozine hcl lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:59970-075
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ZINC OXIDE (ZINC OXIDE) ZINC OXIDE80 mg  in 1 mL
FERRIC OXIDE RED (FERRIC OXIDE RED) FERRIC OXIDE RED80 mg  in 1 mL
PRAMOXINE HYDROCHLORIDE (PRAMOXINE) PRAMOXINE HYDROCHLORIDE10 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
ALCOHOL 
CAMPHOR (NATURAL) 
HYPROMELLOSES 
METHYLPARABEN 
POLYSORBATE 80 
PROPYLENE GLYCOL 
PROPYLPARABEN 
WATER 
XANTHAN GUM 
Product Characteristics
ColorpinkScore    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage Description
1NDC:59970-075-01177 mL in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34706/03/2013
Labeler - Navarro Discount Pharmacies, LLC (094930963)
Registrant - Kareway Product, Inc. (121840057)

 
Navarro Discount Pharmacies, LLC

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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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