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Calamine by Liberty Procurement, Inc

Dosage form: lotion
Ingredients: FERRIC OXIDE RED 8.6mg in 1mL, zinc oxide 20mg in 1mL, PRAMOXINE HYDROCHLORIDE 10mg in 1mL
Labeler: Liberty Procurement, Inc
NDC Code: 63940-336

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%

Pramoxind HCl 1%

Purpose

Skin protectant

External analgesic

Uses
  • for the temporary relief of pain and itching associated with minot skin irritations and rashes due to poison ivy, poison oak, or poison sumac
  • 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
  • condition worsens
  • symptoms last more than 7 days or clean 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 applying was affected are of skin

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 - do not use, ask a doctor

Other information

store at room temperature (59°-77°F)

Inactive ingredients

alcohol, camphor, diazolidinyl urea, fragrance, hypromellose, methylparaben, oil of lavender, oil of rosemary, polysorbate 80, propylene glycol, propylparaben, purified water, xanthan gum

Distributed by

Liberty Procurement, Inc.

650 Liberty Ave.

Union, NJ 07083 USA

Visit us at: www.facevalues.com

SATISFACTION GUARANTEED

Or Your Money Back

DSP-TN-15000

DSP-MO-34

SDS-TN-15012

336.002/336AF

PRINCIPAL DISPLAY PANEL

CORE VALUES

MEDICATED

Calamine Itch Relief Lotion

EXTERNAL ANALGESIC

SKIN PROTECTANT

Drying action PLUS itch relief

6 FL OZ (177 mL)

CALAMINE 
calamine, pramoxind hcl lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63940-336
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
FERRIC OXIDE RED (FERRIC OXIDE RED) FERRIC OXIDE RED8.6 mg  in 1 mL
zinc oxide (zinc oxide) zinc oxide20 mg  in 1 mL
PRAMOXINE HYDROCHLORIDE (PRAMOXINE) PRAMOXINE HYDROCHLORIDE10 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
ALCOHOL 
CAMPHOR (SYNTHETIC) 
DIAZOLIDINYL UREA 
HYPROMELLOSE, UNSPECIFIED 
METHYLPARABEN 
LAVENDER OIL 
ROSEMARY OIL 
POLYSORBATE 80 
PROPYLENE GLYCOL 
PROPYLPARABEN 
water 
XANTHAN GUM 
Packaging
#Item CodePackage Description
1NDC:63940-336-30177 mL in 1 BOTTLE, PLASTIC
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34709/08/2016
Labeler - Liberty Procurement, Inc (804085293)
Registrant - Vi-Jon (790752542)
Establishment
NameAddressID/FEIOperations
Vi-Jon790752542manufacture(63940-336)

 
Liberty Procurement, Inc

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Medically reviewed on Nov 16, 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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