Lavender Callus Remover
Lavender Callus Remover Gel
Approved
Approval ID
4763bab3-631a-4fcf-8387-d7df4e89e0e4
Product Type
HUMAN OTC DRUG LABEL
Effective Date
May 9, 2025
Manufacturers
FDA
SANSAR, LLC
DUNS: 127927811
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Salicylic Acid 12%
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code83691-012
Application NumberM030
Product Classification
M
Marketing Category
C200263
G
Generic Name
Salicylic Acid 12%
Product Specifications
Route of AdministrationTOPICAL
Effective DateMay 9, 2025
FDA Product Classification
INGREDIENTS (6)
SALICYLIC ACIDActive
Quantity: 12 g in 100 mL
Code: O414PZ4LPZ
Classification: ACTIB
POTASSIUM HYDROXIDEInactive
Code: WZH3C48M4T
Classification: IACT
GLYCERINInactive
Code: PDC6A3C0OX
Classification: IACT
EDETATE SODIUMInactive
Code: MP1J8420LU
Classification: IACT
1-ETHOXYUNDECANEInactive
Code: R428J6A8Q2
Classification: IACT
LAVENDER OILInactive
Code: ZBP1YXW0H8
Classification: IACT
Drug Labeling Information
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
LOINC: 51945-4Updated: 5/9/2025
INDICATIONS & USAGE SECTION
LOINC: 34067-9Updated: 5/9/2025
Uses
- for the removal of corns and calluses
- Relieves pain by removing corns and calluses
OTC - ACTIVE INGREDIENT SECTION
LOINC: 55106-9Updated: 5/9/2025
Active ingredient
Salicylic acid 12%
OTC - PURPOSE SECTION
LOINC: 55105-1Updated: 5/9/2025
Purpose
Corn and callus remover
WARNINGS SECTION
LOINC: 34071-1Updated: 5/9/2025
Warnings
For external use only.
OTC - DO NOT USE SECTION
LOINC: 50570-1Updated: 5/9/2025
Do not use on Children under 2 without a Doctor's advice.
OTC - WHEN USING SECTION
LOINC: 50567-7Updated: 5/9/2025
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.
OTC - STOP USE SECTION
LOINC: 50566-9Updated: 5/9/2025
Stop use if irritation occurs
OTC - KEEP OUT OF REACH OF CHILDREN SECTION
LOINC: 50565-1Updated: 5/9/2025
Keep out of the reach of children. If swallowed, get medical help or contact a Poison Control Center immediately.
DOSAGE & ADMINISTRATION SECTION
LOINC: 34068-7Updated: 5/9/2025
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 INGREDIENT SECTION
LOINC: 51727-6Updated: 5/9/2025
Inactive Ingredients
Distilled water, Alcohol ethoxylate, Potassium Hydroxide, Glycerin, Tetrasodium EDTA, Fragrance Essential Oil