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Camphor 4% Plus Menthol 10%

59088-259-07 Camphor 4% + Menthol 10%

Approved
Approval ID

3cab26e4-e377-f26a-e063-6394a90a17af

Product Type

HUMAN OTC DRUG LABEL

Effective Date

Aug 20, 2025

Manufacturers
FDA

PureTek Corporation

DUNS: 785961046

Products 1

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

Camphor 4% Plus Menthol 10%

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code59088-259
Application NumberM017
Product Classification
M
Marketing Category
C200263
G
Generic Name
Camphor 4% Plus Menthol 10%
Product Specifications
Route of AdministrationTOPICAL
Effective DateAugust 20, 2025
FDA Product Classification

INGREDIENTS (16)

ALCOHOLInactive
Code: 3K9958V90M
Classification: IACT
ILEX PARAGUARIENSIS LEAFInactive
Code: 1Q953B4O4F
Classification: IACT
INDIAN FRANKINCENSEInactive
Code: 4PW41QCO2M
Classification: IACT
CHONDROITIN SULFATE (BOVINE)Inactive
Code: 6IC1M3OG5Z
Classification: IACT
MAGNESIUM CHLORIDEInactive
Code: 02F3473H9O
Classification: IACT
MENTHA PIPERITA (PEPPERMINT) OILInactive
Code: AV092KU4JH
Classification: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
MENTHOLActive
Quantity: 100 mg in 1 g
Code: L7T10EIP3A
Classification: ACTIB
GLUCOSAMINE SULFATEInactive
Code: 1FW7WLR731
Classification: IACT
GLYCERINInactive
Code: PDC6A3C0OX
Classification: IACT
CAMPHOR (SYNTHETIC)Active
Quantity: 40 mg in 1 g
Code: 5TJD82A1ET
Classification: ACTIB
EUCALYPTUS GLOBULUS LEAF OILInactive
Code: 2R04ONI662
Classification: IACT
DIMETHYL SULFONEInactive
Code: 9H4PO4Z4FT
Classification: IACT
TRIETHANOLAMINEInactive
Code: 9O3K93S3TK
Classification: IACT
METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (4500 MPA.S)Inactive
Code: T967IEU43C
Classification: IACT

Drug Labeling Information

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LOINC: 51945-4Updated: 8/18/2025

Camphor 4 % + Menthol 10%

​Manufactured by:

PureTek Corporation
Panorama City, CA 91402
For questions or information
call toll-free: 877-921-7873Label

INDICATIONS & USAGE SECTION

LOINC: 34067-9Updated: 8/18/2025

Uses

for the temporary relief of minor aches and pains of muscles and joints associated with simple backache, arthritis, strains, bruises and sprains, etc.

OTC - ACTIVE INGREDIENT SECTION

LOINC: 55106-9Updated: 8/18/2025

Active Ingredients

Camphor 4%

Menthol 10%

OTC - PURPOSE SECTION

LOINC: 55105-1Updated: 8/18/2025

Purpose

Analgesic (pain relief)

WARNINGS SECTION

LOINC: 34071-1Updated: 8/18/2025

Warnings

For external use only

Do not use on

  • wounds
  • damaged skin

When using this product

  • avoid getting into eyes or mucous membranes
  • do not bandage tightly

Stop use and ask a doctor if

  • excessive irritation of the skin develops
  • condition worsens
  • symptoms last more than 7 days or clear up and occur again within a few days

If pregnant or breast-feeding

ask a health professional before use.

Keep out of reach of children

If swallowed, get medical help or contact a Poison Control Center right away.

DOSAGE & ADMINISTRATION SECTION

LOINC: 34068-7Updated: 8/18/2025

Directions

  • adults and children 12 years of age or older: using the roll-on applicator massage a liberal amount of gel directly on the affected area, not more than 3 to 4 times daily.
  • children under the age of 12: do not use, consult a doctor
  • use only as directed

STORAGE AND HANDLING SECTION

LOINC: 44425-7Updated: 8/18/2025

Other information

  • keep container tightly closed
  • store at 20° to 25°C (68° to 77°F)

INACTIVE INGREDIENT SECTION

LOINC: 51727-6Updated: 8/18/2025

Inactive ingredients

Acrylates Copolymer, Alcohol Denat., Boswellia Serrata Extract, Chondroitin Sulfate, Eucalyptus Globulus Leaf Oil, Glucosamine Sulfate, Glycerin, Ilex Paraguariensis (Yerba Mate) Leaf Powder, Magnesium Chloride, Mentha Piperita (Peppermint) Oil, MSM (Methylsulfonylmethane), Propylene Glycol, Triethanolamine, Water.

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