MEDICATED BODY POWDER- menthol powder

Medicated Body by

Drug Labeling and Warnings

Medicated Body by is a Otc medication manufactured, distributed, or labeled by New Pride Corp, Jell Pharmaceuticals pvt ltd, Jell Pharmaceuticals Pvt Ltd.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts Active Ingredients

Menthol 0.15 %

Purpose

External Analgesic

Uses

for the temporary relief of the pain and itch associated with

• minor cuts
• scrapes
• sunburn
• insect bites
• prickly heat
• rashes
• minor burns
• minor skin irritations
• dries the oozing of poison ivy, oak and sumac.

Warnings

For external use only

When usin this product

Avoid contact with eyes. Not for genital area.

Stop use and ask a doctor if

• condition worsens
• Redness, irritation, swelling or pain persist or increases
• symptoms do not get better within 7 days or clear up and occur again within a few days

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 (1-800-222-1222) right away.

Directions

• adults and children 2 years of age and over, apply freely up to 3 or 4 times daily
• Children under 2 years: consult a physician
• for best results, dry skin thoroughly before use

Inactive Ingredients

acacia seyl gum, eucalyptol, methyl salicylate, salicylic acid, sodium bicarbonate, thymol, tricalciun phosphate, zea mays (corn stach), zinc oxide, zinc stearate

Equate Medicated Body Powder Original

INGREDIENTS AND APPEARANCE

MEDICATED BODY  POWDER
menthol powder

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 58037-001
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL	0.42 g  in 283 g

Inactive Ingredients
Ingredient Name	Strength
SODIUM BICARBONATE (UNII: 8MDF5V39QO)
TRICALCIUM PHOSPHATE (UNII: K4C08XP666)
ACACIA (UNII: 5C5403N26O)
EUCALYPTUS OIL (UNII: 2R04ONI662)
MENTHYL SALICYLATE, (+/-)- (UNII: 43XOA705ZD)
SALICYLIC ACID (UNII: O414PZ4LPZ)
THYMOL (UNII: 3J50XA376E)
ZINC STEARATE (UNII: H92E6QA4FV)
ZINC OXIDE (UNII: SOI2LOH54Z)
ZEA MAYS WHOLE (UNII: 1G5HNE09V8)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 58037-001-01	283 g in 1 BOTTLE; Type 0: Not a Combination Product	09/01/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part348	09/01/2020

Labeler - New Pride Corp (884264198)

Registrant - Jell Pharmaceuticals pvt ltd (726025211)

Establishment
Name	Address	ID/FEI	Business Operations
Jell Pharmaceuticals Pvt Ltd.		726025211	manufacture(58037-001)