Health Smart Medicated Body Powder (Talc Free)

Active Ingredients

Menthol 0.15%

Zinc Oxide 1.0%

Purpose

External Analgesic

Skin Protectant

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

For external use only.

When using this productavoid contact with eyes.

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

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

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 Ingredients

acacia seyal gum, eucalyptus oil, methyl salicylate, salicylic acid, sodium bicarbonate, thymol, tricalcium phosphate, zea mays (corn starch) zinc stearate.

PRINCIPAL DISPLAY PANEL

HEALTH SMART MEDICATED BODY POWDER

NET WT. 10 OZ. (283g)

Label

HEALTH SMART MEDICATED BODY
menthol and zinc oxide powder

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:52862-030
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
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

Ingredient Name	Strength
Inactive Ingredients
TRICALCIUM PHOSPHATE (UNII: K4C08XP666)
SODIUM BICARBONATE (UNII: 8MDF5V39QO)
SALICYLIC ACID (UNII: O414PZ4LPZ)
ACACIA (UNII: 5C5403N26O)
EUCALYPTUS OIL (UNII: 2R04ONI662)
METHYL SALICYLATE (UNII: LAV5U5022Y)
THYMOL (UNII: 3J50XA376E)
ZINC STEARATE (UNII: H92E6QA4FV)
ZEA MAYS SUBSP. MAYS WHOLE (UNII: 1G5HNE09V8)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:52862-030-01	283 g in 1 BOTTLE; Type 0: Not a Combination Product	08/01/2020

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

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

Registrant - Jell Pharmaceuticals Pvt. Ltd. (726025211)

Name	Address	ID/FEI	Business Operations
Establishment
Jell Pharmaceuticals Pvt. Ltd.		726025211	manufacture(52862-030)