FOOT SOAK by Xtreme Tools International, Inc FOOT SOAK

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]

FOOT SOAK- menthol, methyl salicylate crystal 
Xtreme Tools International, Inc

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FOOT SOAK

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. 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

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

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	03/12/2025

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M017	11/25/2020	03/12/2025

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)

Revised: 3/2025

Document Id: b6937a24-2880-411a-a217-e7d0206598d7

34390-5

Set id: b4eb8841-196e-133a-e053-2a95a90a9400

Version: 3

Effective Time: 20250312