CALAMINE- zinc oxide, ferric oxide red, pramozine hcl lotion 
Navarro Discount Pharmacies, LLC

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:

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

Other information

Inactive ingredients

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

Package Label

image of bottle label

CALAMINE 
zinc oxide, ferric oxide red, pramozine hcl lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:59970-075
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE80 mg  in 1 mL
FERRIC OXIDE RED (UNII: 1K09F3G675) (FERRIC OXIDE RED - UNII:1K09F3G675) FERRIC OXIDE RED80 mg  in 1 mL
PRAMOXINE HYDROCHLORIDE (UNII: 88AYB867L5) (PRAMOXINE - UNII:068X84E056) PRAMOXINE HYDROCHLORIDE10 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
ALCOHOL (UNII: 3K9958V90M)  
CAMPHOR (NATURAL) (UNII: N20HL7Q941)  
HYPROMELLOSES (UNII: 3NXW29V3WO)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
PROPYLPARABEN (UNII: Z8IX2SC1OH)  
WATER (UNII: 059QF0KO0R)  
XANTHAN GUM (UNII: TTV12P4NEE)  
Product Characteristics
ColorpinkScore    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
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)

Revised: 5/2013
Document Id: 31cda82e-11b2-4537-9f32-f54b01141bb8
Set id: 7f2c5adf-92ca-4257-b71b-f7578a481c92
Version: 1
Effective Time: 20130506
 
Navarro Discount Pharmacies, LLC