Cetilar

Cetilar
SPL v1
SPL
SPL Set ID 2dd14bd4-b4e1-bc7d-e063-6394a90a1e59
Route
TOPICAL
Published
Effective Date 2025-02-01
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Menthol (1.4 g)
Inactive Ingredients
Glycerin Butylene Glycol Apricot Seed Oil Water Glyceryl Stearate Phenoxyethanol .alpha.-tocopherol Acetate, D- Caprylic/capric Triglyceride Triethanolamine Wheat Germ Oil Unsaponifiables Beeswax Polyacrylic Acid (8000 Mw) Cetyl Alcohol Butylated Hydroxytoluene Cetyl Myristate Perfluoropolymethylisopropyl Ether Isopropyl Myristate Ethylhexylglycerin

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-02-01

Description

Menthol 1.4%

Purpose

Topical Analgesic


Medication Information

Purpose

Topical Analgesic

Description

Menthol 1.4%

Use

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

Section 51945-4

Warnings

For external use only. Avoid contact with eyes

Directions

Adults and children over 12 years:

  • Apply to the affect area not more than 3 to 4 times daily
  • After applying, wash hands with soap and water

Children 12 years or younger, consult a doctor

Active Ingredient

Menthol 1.4%

Other Information

The product must be stored at temperature between 50-86 °F (10-30ºC), in a dry place away from light localized heat sources.

Inactive Ingredients

water, cetyl myristate, Glycerin, Cetyl alcohol, Glyceryl stearate, olea europea (olive ) oil unsaponifiables, cetyloleate, Butylene glycol, Caprylic capric triglyceride, prunus armeniaca (apricot) kenel oil, Beeswax, Phenoxyethanol, Triethanolamine, carbomer, fragrance, isopropyl myristate, ethylhexylglycerin, triticum vulgare (wheat) germ oil, BHT, tocopheryl acetate.

When Using This Product
  • Do not bandage tightly
  • do not apply to wounds or damage skin
Stop Use and Ask A Doctor
  • if condition worsens
  • if symptoms persist for 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


Structured Label Content

Use

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

Section 51945-4 (51945-4)

Purpose

Topical Analgesic

Warnings

For external use only. Avoid contact with eyes

Directions

Adults and children over 12 years:

  • Apply to the affect area not more than 3 to 4 times daily
  • After applying, wash hands with soap and water

Children 12 years or younger, consult a doctor

Active Ingredient

Menthol 1.4%

Other Information

The product must be stored at temperature between 50-86 °F (10-30ºC), in a dry place away from light localized heat sources.

Inactive Ingredients (Inactive ingredients)

water, cetyl myristate, Glycerin, Cetyl alcohol, Glyceryl stearate, olea europea (olive ) oil unsaponifiables, cetyloleate, Butylene glycol, Caprylic capric triglyceride, prunus armeniaca (apricot) kenel oil, Beeswax, Phenoxyethanol, Triethanolamine, carbomer, fragrance, isopropyl myristate, ethylhexylglycerin, triticum vulgare (wheat) germ oil, BHT, tocopheryl acetate.

When Using This Product (When using this product)
  • Do not bandage tightly
  • do not apply to wounds or damage skin
Stop Use and Ask A Doctor (Stop use and ask a doctor)
  • if condition worsens
  • if symptoms persist for more than 7 days or clear up and occur again within a few days
If Pregnant Or Breast Feeding (If pregnant or breast-feeding)

ask a health professional before use

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


Advanced Ingredient Data


Raw Label Data

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