Drug Facts

Drug Facts
SPL v2
SPL
SPL Set ID 16918ba3-2e07-4232-9ed3-4c7751796cd2
Route
TOPICAL
Published
Effective Date 2022-05-31
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Menthol, Unspecified Form (110 mg) Camphor (synthetic)
Inactive Ingredients
Cajuput Oil Chinese Cinnamon Oil Clove Oil Peppermint Oil Terpeneless Paraffin Petrolatum

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2022-05-31

Description

Camphor 11 % Menthol 11%

Purpose

Topical Analgesic Topical Analgesic


Medication Information

Purpose

Topical Analgesic

Topical Analgesic

Description

Camphor 11 % Menthol 11%

Uses

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

  • Over-Exertion
  • Simple backache
  • Arthritis
  • Strains
  • Sprains
Section 42229-5

Adults and children 12 years of age and over:rub on affected area; repeat 3 to 4 times daily

Section 50565-1

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

Section 53414-9

If pregnant or breastfeeding,ask a health professional before use.

Warnings

For external use only.

Other Information

This product may cause allergic reaction in some individuals. Test on small area before use.

Active Ingredients

Camphor 11 %

Menthol 11%

Inactive Ingredients

Cajeput Oil, Cassia Oil, Clove Oil, Dementholized Mint Oil, Paraffin, Petrolatum

When Using This Product
  • avoid contact with eyes or mucous membranes
  • do not apply to open wounds or damaged skin
  • do not bandage or use a heating pad
Stop Use and Ask A Doctor If
  • condition worsens
  • severe skin irritation occurs
  • pain persists for more than 7 days
  • pain clears up then recurs a few days later
Principal Display Panel – 18 G Jar Label

NATURE'S OIL

Muscle Balm

Intense Strength

Muscle Relieving Ointment

Net wt 0.63 oz (18 g)


Structured Label Content

Uses

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

  • Over-Exertion
  • Simple backache
  • Arthritis
  • Strains
  • Sprains
Section 42229-5 (42229-5)

Adults and children 12 years of age and over:rub on affected area; repeat 3 to 4 times daily

Section 50565-1 (50565-1)

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

Section 53414-9 (53414-9)

If pregnant or breastfeeding,ask a health professional before use.

Purpose

Topical Analgesic

Topical Analgesic

Warnings

For external use only.

Other Information

This product may cause allergic reaction in some individuals. Test on small area before use.

Active Ingredients (Active ingredients)

Camphor 11 %

Menthol 11%

Inactive Ingredients (Inactive ingredients)

Cajeput Oil, Cassia Oil, Clove Oil, Dementholized Mint Oil, Paraffin, Petrolatum

When Using This Product (When using this product)
  • avoid contact with eyes or mucous membranes
  • do not apply to open wounds or damaged skin
  • do not bandage or use a heating pad
Stop Use and Ask A Doctor If (Stop use and ask a doctor if)
  • condition worsens
  • severe skin irritation occurs
  • pain persists for more than 7 days
  • pain clears up then recurs a few days later
Principal Display Panel – 18 G Jar Label (Principal Display Panel – 18 g Jar Label)

NATURE'S OIL

Muscle Balm

Intense Strength

Muscle Relieving Ointment

Net wt 0.63 oz (18 g)


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)