HEALTH SMART MEDICATED BODY- menthol and zinc oxide powder

Health Smart Medicated Body by

Drug Labeling and Warnings

Health Smart Medicated Body by is a Otc medication manufactured, distributed, or labeled by International Wholesale Inc dba Home Smart Products, 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

External Analgesic

Skin Protectant

INDICATIONS & USAGE

Uses

For the temporary relief of pains and itch associated with:

• Minor Cuts
• Scrapes
• Sunburn
• Insect Bites
• Prickly Heat
• Rashes
• Minor Burns
• Minor Skin Irritation
• Dries the oozing of poison ivy, oak, and sumac.

WARNINGS

Warnings

For external use only.

WHEN USING

When using this product avoid contact with eyes.

ASK DOCTOR

Consult a doctor and discontinue use if

• condition worsens
• symptoms do not get better within 1 week or clear up and occurs again within a few days.

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

adults and children 2 years and over

• apply to the affected area not more than 3 or 4 times daily.
• children under 2 years of age: consult a physician.
• for best results, dry skin thoroughly before use.

INACTIVE INGREDIENT

Inactive Ingredients

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

SPL UNCLASSIFIED SECTION

PRINCIPAL DISPLAY PANEL

HEALTH SMART MEDICATED BODY POWDER

NET WT. 10 OZ. (283g)

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

HEALTH SMART MEDICATED BODY 
menthol and zinc oxide powder

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 52862-020
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: 52862-020-22	283 g in 1 BOTTLE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part348	02/27/2014

Labeler - International Wholesale Inc dba Home Smart Products (161872676)

Registrant - Jell Pharmaceuticals Pvt. Ltd. (726025211)

Establishment
Name	Address	ID/FEI	Business Operations
Jell Pharmaceuticals Pvt. Ltd.		726025211	manufacture(52862-020)