FOOT SOAK- menthol, methyl salicylate crystal

FOOT SOAK by

Drug Labeling and Warnings

FOOT SOAK by is a Otc medication manufactured, distributed, or labeled by Xtreme Tools International, Inc. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredients

Menthol 5%

Methyl Salicylate 5%

Purpose

Topical Analgesic

Use

For the Temporary relief of minor pain.

Warning

For External use only.

If pregnant or breast-feeding, ask a health professional before use.

Allergy Alert:
If prone to allergic reaction from aspirin or salicylate, consult a doctor before use.

When using this product

Avoid contact with eyes. If contact occurs, rinse eyes thoroughly with water.

Stop use and ask a doctor if

Condition worsens or does not improve after regular use of this product.

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Directions

Pour a desired amount of Foot Soak into pan or tub of warm water. Soak for as long as desired.

Inactive ingredients

Sodium Chloride (Himalayan Pink Salt)

Questions or comments?

Call 1-305-622-7474 Monday through Friday 9:00 AM to 5:00 PM

Package Label

1133 gr in JAR; NDC: 74553-005-01

INGREDIENTS AND APPEARANCE

FOOT SOAK 
menthol, methyl salicylate crystal

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 74553-005
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
METHYL SALICYLATE (UNII: LAV5U5022Y) (SALICYLIC ACID - UNII:O414PZ4LPZ)	METHYL SALICYLATE	5 g  in 100 g
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL	5 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
SODIUM CHLORIDE (UNII: 451W47IQ8X)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 74553-005-01	1133 g in 1 JAR; Type 0: Not a Combination Product	11/25/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part348	11/25/2020

Labeler - Xtreme Tools International, Inc (125398904)

Registrant - Xtreme Tools International, Inc (125398904)

Establishment
Name	Address	ID/FEI	Business Operations
Xtreme Tools International, Inc		125398904	manufacture(74553-005)