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Medicated Body Powder by Rejoice International Inc.

Medically reviewed on June 18, 2018

Dosage form: powder
Ingredients: MENTHOL 0.15g in 100g, ZINC OXIDE 1g in 100g
Labeler: Rejoice International Inc.
NDC Code: 57337-079

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.

Active Ingredients                      Purpose

Menthol 1.0% ............................... Anti-itch

Uses

temporarily relieves the pain and itch associated with minor skin irritation on the foot

  • provides itch relief
  • absorbs excess moisture
  • helps control foot odor and odor-causing bacteria
  • cools and soothes irritated skin

Keep out of reach of children. In case of accidental ingestion, get medical help or contact a Poison Control Center right away.

XtraCare

Medicated Foot Powder

3x Action

Itch Relieving

Odor Controlling

Moisture Absorbing

Directions

adults and children 2 years and older                     apply freely up to 3 or 4 times daily

children under 2 years                                           ask a doctor before using

Thoroughly wash and dry feet, sprinkle powder liberally over feet, between toes, and on bottom of feet. For best results apply to affected areas up to 3 or 4 times daily.  Sprinkle inside shoes for maximum freshness.

Warnings

For external use only

  • avoid contact with eyes

Stop using and ask a doctor if

  • condition worsens
  • symptoms do not get better within 7 days

Inactive ingredients talc, sodium bicarbonate, acacia, benzethonium chloride, eucalyptus oil, peppermint oil

MEDICATED BODY POWDER 
menthol powder
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:57337-079
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MENTHOL (MENTHOL) MENTHOL0.15 g  in 100 g
ZINC OXIDE (ZINC CATION) ZINC CATION1 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
TALC 
METHYL SALICYLATE 
ACACIA 
SALICYLIC ACID 
EUCALYPTOL 
THYMOL 
ZINC STEARATE 
Packaging
#Item CodePackage Description
1NDC:57337-079-01283 g in 1 PACKAGE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34806/15/2015
Labeler - Rejoice International Inc. (078741245)
Establishment
NameAddressID/FEIOperations
Jell Pharmaceuticals Pvt. Ltd.726025211manufacture(57337-079)

 
Rejoice International Inc.

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Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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