SPL v1
SPL
SPL Set ID cfb2ea0e-a1f6-4fdf-b866-346bbe78788f
Route
TOPICAL
Published
Effective Date 2025-06-20
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Camphor (natural) (10.8 g) Menthol (11 g)
Inactive Ingredients
Borneol Chinese Cinnamon Oil Cinnamon Leaf Oil Citronella Oil Clove Oil Nutmeg Oil Paraffin Peppermint Oil White Petrolatum Eucalyptus Oil

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-07-01

Description

Camphor 10.8%................................Topical Analgesic Menthol Crystal 11%.........................Topical Analgesic


Medication Information

Description

Camphor 10.8%................................Topical Analgesic Menthol Crystal 11%.........................Topical Analgesic

Uses

For the temporary relief of minor aches & pains of muscles and joints associated with:

  • arthritis & rheumatism 
  • backaches 
  • strains 
  • bruises 
  • sprains 
  • leg cramps
Section 50565-1

Section 55105-1

Warnings

For external use only.

When using this product:

  • Avoid contact with the eyes
  • Do not apply to wounds or damaged skin 
  • Do not bandage tightly 
  • Do not use with heating pads or heating devices

Stop use and consult a doctor ifcondition worsens, or if symptoms persist for more than 7 days or clear up and occur again within a few days, discontinue use of this product and consult a physician.

If pregnant or breast-feeding, ask a health care professional before use

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

Directions
  • Adults and children 2 years of age and older apply to affected area not more than 3 to 4 times daily. 
  • Children under 2 years of age: do not use, consult a physician.
Product Label

Other Information
  • Store in a cool dry place 20° to 25° C (68° to 77° F). 
  • This product may cause allergic reaction in some individuals. 
  • Test on small area before use. Do not use if seal is broken
Active Ingredients

Camphor 10.8%................................Topical Analgesic

Menthol Crystal 11%.........................Topical Analgesic

Inactive Ingredients

Borneol, Cassia Oil, Cinnamon Leaf Oil, Citronella Oil, Clove Oil, Eucalyptus Oil, Nutmeg Oil, Paraffin Wax, Peppermint Oil, Soft White Paraffin


Structured Label Content

Uses

For the temporary relief of minor aches & pains of muscles and joints associated with:

  • arthritis & rheumatism 
  • backaches 
  • strains 
  • bruises 
  • sprains 
  • leg cramps
Section 50565-1 (50565-1)

Section 55105-1 (55105-1)

Warnings

For external use only.

When using this product:

  • Avoid contact with the eyes
  • Do not apply to wounds or damaged skin 
  • Do not bandage tightly 
  • Do not use with heating pads or heating devices

Stop use and consult a doctor ifcondition worsens, or if symptoms persist for more than 7 days or clear up and occur again within a few days, discontinue use of this product and consult a physician.

If pregnant or breast-feeding, ask a health care professional before use

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

Directions
  • Adults and children 2 years of age and older apply to affected area not more than 3 to 4 times daily. 
  • Children under 2 years of age: do not use, consult a physician.
Product Label (Product label)

Other Information (Other information)
  • Store in a cool dry place 20° to 25° C (68° to 77° F). 
  • This product may cause allergic reaction in some individuals. 
  • Test on small area before use. Do not use if seal is broken
Active Ingredients

Camphor 10.8%................................Topical Analgesic

Menthol Crystal 11%.........................Topical Analgesic

Inactive Ingredients

Borneol, Cassia Oil, Cinnamon Leaf Oil, Citronella Oil, Clove Oil, Eucalyptus Oil, Nutmeg Oil, Paraffin Wax, Peppermint Oil, Soft White Paraffin


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)