MEDICATED BODY- menthol and zinc oxide powder

Medicated Body by

Drug Labeling and Warnings

Medicated Body by is a Otc medication manufactured, distributed, or labeled by Universal Distribution Center LLC, Jell Pharmaceuticals Pvt. Ltd.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active Ingredients

Menthol        0.15%

Zinc Oxide      1.0%

PURPOSE

Purpose

Anti-itch

INDICATIONS & USAGE

Uses

For the temporary relief from pain and itching associated with minor cuts and burns, sunburn, scrapes, insect bites, and other minor skin irritation. Also for drying up poison oak, which helps control the growth of fungi associated with athlete's foot and jock itch.

WARNINGS

Warning

For external use only.

WHEN USING

Avoid contact with eyes.

ASK DOCTOR

If symptoms persist more than 7 days, worsen with use or return within a few days of cleaning up, discontinue use of this product and consult a doctor.

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children

In case of accidental ingestion, seek professional assistance or contact a Poison Control Center immediately.

DOSAGE & ADMINISTRATION

Directions

Use after shower, bath or exercise. Use in footwear and on feet. Dry skin completely before applying. For adults and children over 2 years; apply to affected area not more than 3 or 4 times daily. Children Under 2 Years; Consult a doctor.

INACTIVE INGREDIENT

Inactive Ingredients

talc, acacia, eucalyptus oil, methyl salicylate, salicylic acid, thymol, zinc stearate.

PRINCIPAL DISPLAY PANEL

PRINCIPAL DISPLAY PANEL

MEDICATED BODY POWDER

NET WT. 10 OZ. (283g)

INGREDIENTS AND APPEARANCE

MEDICATED BODY 
menthol and zinc oxide powder

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 52000-024
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 OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	1 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
TALC (UNII: 7SEV7J4R1U)
ACACIA (UNII: 5C5403N26O)
EUCALYPTUS OIL (UNII: 2R04ONI662)
METHYL SALICYLATE (UNII: LAV5U5022Y)
SALICYLIC ACID (UNII: O414PZ4LPZ)
THYMOL (UNII: 3J50XA376E)
ZINC STEARATE (UNII: H92E6QA4FV)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 52000-024-25	283 g in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part348	11/03/2015

Labeler - Universal Distribution Center LLC (019180459)

Registrant - Jell Pharmaceuticals Pvt. Ltd. (726025211)

Establishment
Name	Address	ID/FEI	Business Operations
Jell Pharmaceuticals Pvt. Ltd.		726025211	manufacture(52000-024)