TEA TREE OIL CALLUS REMOVER- salicylic acid 12% gel

Tea Tree Oil Callus Remover by

Drug Labeling and Warnings

Tea Tree Oil Callus Remover by is a Otc medication manufactured, distributed, or labeled by SANSAR, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredient

Salicylic acid 12%

Purpose

Corn and callus remover

Uses

• for the removal of corns and calluses
• Relieves pain by removing corns and calluses

Warnings

For external use only.

DO NOT USE

Do not use on Children under 2 without a Doctor's advice.

When using this product

• Wear gloves. Limit use to 20 minutes. Use cautiously with electric filing machines.
• Avoid broken or non calloused skin. 
• Avoid eye contact. Rinse for 15 minutes if contcat occurs. consult a physician if irritation persists.

Stop use if irritation occurs

KEEP OUT OF REACH OF CHILDREN

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

Directions 

• Soak feet for 10-15 minutes 
• Dry with a towel
• Wear Gloves, apply callus remover gel, leave for 10-15 minutes.
• Rinse of residue.

Inactive Ingredients 

Distilled water, Alcohol ethoxylate, Potassium Hydroxide, Glycerin, Tetrasodium EDTA

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

TEA TREE OIL CALLUS REMOVER 
salicylic acid 12% gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 83691-007
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ)	SALICYLIC ACID	12 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
POTASSIUM HYDROXIDE (UNII: WZH3C48M4T)
GLYCERIN (UNII: PDC6A3C0OX)
EDETATE SODIUM (UNII: MP1J8420LU)
1-ETHOXYUNDECANE (UNII: R428J6A8Q2)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 83691-007-01	1 in 1 CARTON	05/09/2025
1		236 mL in 1 BOTTLE; Type 0: Not a Combination Product
2	NDC: 83691-007-02	2 in 1 CARTON	05/09/2025
2		236 mL in 1 BOTTLE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M030	05/09/2025

Labeler - SANSAR, LLC (127927811)