MEDICATED FOOT POWDER- menthol powder 
Rejoice International Inc.

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.

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Medicated Foot Powder

Active Ingredients                      Purpose

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

Uses

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

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

Stop using and ask a doctor if

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

image description

MEDICATED FOOT POWDER 
menthol powder
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:57337-078
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL1 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
TALC (UNII: 7SEV7J4R1U)  
SODIUM BICARBONATE (UNII: 8MDF5V39QO)  
ACACIA (UNII: 5C5403N26O)  
BENZETHONIUM CHLORIDE (UNII: PH41D05744)  
EUCALYPTUS OIL (UNII: 2R04ONI662)  
PEPPERMINT OIL (UNII: AV092KU4JH)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:57337-078-01283 g in 1 PACKAGE; Type 0: Not a Combination Product06/15/2015
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34806/15/2015
Labeler - Rejoice International Inc. (078741245)
Registrant - Jell Pharmaceuticals Pvt Ltd. (726025211)
Establishment
NameAddressID/FEIBusiness Operations
Jell Pharmaceuticals Pvt. Ltd.726025211manufacture(57337-078)

Revised: 11/2022
Document Id: edbf34dc-07ed-183d-e053-2a95a90ae61f
Set id: e90a4e39-fe6b-4280-9846-a61af294326f
Version: 5
Effective Time: 20221118
 
Rejoice International Inc.