MAXIMUM STRENGTH MEDICATED FOOT POWDER- medicated foot powder powder

Maximum Strength Medicated Foot Powder by

Drug Labeling and Warnings

Maximum Strength Medicated Foot Powder by is a Otc medication manufactured, distributed, or labeled by Jell Pharmaceuticals Pvt. Ltd., Jell Pharmaceuticals Pvt Ltd.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

​Active ingredient

Menthol 1.0%

​Purpose

External analgesic

​Use

for the temporary relief of pain and itching 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 product

• avoid contact with eyes. Not for genital area

Stop and consult a doctor if

• conditions 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.

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

benzethonium chloride, eucalyptus oil, peppermint oil, sodium bicarbonate, tricalcium phosphate, Zea mays (corn) starch

Maximum Strength Medicated Foot Powder

INGREDIENTS AND APPEARANCE

MAXIMUM STRENGTH MEDICATED FOOT POWDER 
medicated foot powder powder

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 30400-507
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL	0.1 g  in 1 g

Inactive Ingredients
Ingredient Name	Strength
BENZETHONIUM CHLORIDE (UNII: PH41D05744)
EUCALYPTUS OIL (UNII: 2R04ONI662)
TRICALCIUM PHOSPHATE (UNII: K4C08XP666)
PEPPERMINT OIL (UNII: AV092KU4JH)
SODIUM BICARBONATE (UNII: 8MDF5V39QO)
ZEA MAYS WHOLE (UNII: 1G5HNE09V8)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 30400-507-01	283 g in 1 BOTTLE, PLASTIC; 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 Drug	M016	09/01/2020

Labeler - Jell Pharmaceuticals Pvt. Ltd. (726025211)

Registrant - Jell Pharmaceuticals Pvt. Ltd. (726025211)

Establishment
Name	Address	ID/FEI	Business Operations
Jell Pharmaceuticals Pvt Ltd.		726025211	manufacture(30400-507)