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 Ingredients

Menthol         0.15%

Zinc Oxide     1.0%

Purpose

External analgesic

Skin protectant

Uses

for the temporary relief of pain and itching associated with:

• Backache
• Minor Burns
• Minor Skin Irritations
• Minor Cuts
• Sunburn
• Insect Bites
• Ooozing and weeping of poison ivy, poison oak and poison sumac can be dried using Universal Medicated Powder

Warnings

For external use only.

WHEN USING

When using this product avoid contact with the eyes.

STOP USE

Stop use and ask a doctor if condition worsens, or if symptoms persist for more than 7 days or clear up and occur again within a few days.

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center  (1-800-222-1222) immediately.

Directions

• Adults and children 2 years of age and older: apply to affected area no more than 3 to 4 times daily
• Children under 2 years of age: consult a doctor
• For best results, dry area thoroughly before applying

Inactive Ingredients

Zea mays (corn) starch, sodium bicarbonate,  tricalcium phosphate, acacia seyal gum, eucalyptol, methyl salicylate, salicylic acid, thymol, zinc stearate

SPL UNCLASSIFIED SECTION

This product is sold by weight, not by volume. Some settling may occur during handling and shipping.

PRINCIPAL DISPLAY PANEL

Principal Display Panel

Medicated Body Powder

NET WT. 10 oz (283 g)

INGREDIENTS AND APPEARANCE

MEDICATED BODY 
menthol and zinc oxide powder

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 52000-038
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL	1.5 mg  in 1 g
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37)	ZINC CATION	10 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
STARCH, CORN (UNII: O8232NY3SJ)
SODIUM BICARBONATE (UNII: 8MDF5V39QO)
TRICALCIUM PHOSPHATE (UNII: K4C08XP666)
GUM TALHA (UNII: H18F76G097)
EUCALYPTOL (UNII: RV6J6604TK)
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: 52000-038-25	283 g in 1 BOTTLE; Type 0: Not a Combination Product	12/04/2017

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part348	12/04/2017

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(52000-038)