MEDICATED BODY POWDER- menthol powder

Medicated Body Powder by

Drug Labeling and Warnings

Medicated Body Powder by is a Otc medication manufactured, distributed, or labeled by Rejoice International Inc., Jell Pharmaceuticals Pvt Ltd., Jell Pharmaceuticals Pvt. Ltd.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active Ingredients                      Purpose

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

PURPOSE

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

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

INDICATIONS & USAGE

XtraCare

Medicated Foot Powder

3x Action

Itch Relieving

Odor Controlling

Moisture Absorbing

DOSAGE & ADMINISTRATION

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

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 INGREDIENT

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

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

MEDICATED BODY POWDER 
menthol powder

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 57337-079
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL	0.15 g  in 100 g
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37)	ZINC CATION	1 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
TALC (UNII: 7SEV7J4R1U)
METHYL SALICYLATE (UNII: LAV5U5022Y)
ACACIA (UNII: 5C5403N26O)
SALICYLIC ACID (UNII: O414PZ4LPZ)
EUCALYPTOL (UNII: RV6J6604TK)
THYMOL (UNII: 3J50XA376E)
ZINC STEARATE (UNII: H92E6QA4FV)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 57337-079-01	283 g in 1 PACKAGE; Type 0: Not a Combination Product	06/15/2015

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part348	06/15/2015

Labeler - Rejoice International Inc. (078741245)

Establishment
Name	Address	ID/FEI	Business Operations
Jell Pharmaceuticals Pvt. Ltd.		726025211	manufacture(57337-079)