Drug Facts

Drug Facts

SPL v2

SPL

SPL Set ID 5aec103e-3507-4a52-95c1-6e58ddffc500

Route

TOPICAL

Published

Effective Date 2021-02-04

Document Type 34390-5 HUMAN OTC DRUG LABEL

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 2021-02-04

Description

Camphor 11 % Menthol 11 %

Purpose

Topical analgesic Topical analgesic

Medication Information

Purpose

Topical analgesic

Description

Camphor 11 % Menthol 11 %

Uses

For temporary relief of minor aches and pains of muscles and joints associated with over-exertion, simple backache, arthritis, strains and sprains.

Section 50565-1

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

Section 53414-9

If pregnant or breast feeding, ask a healthcare professional before use

Warnings

For external use only

Directions

rub on affected area. Repeat 3 to 4 times daily.
for adults and children 12 and over
under 12 consult doctor before use

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 and Paraffin Petrolatum

When Using This Product

avoid contact with eyes and mucous membranes
do not apply to open wounds or damaged skin
do not bandage or use heating pad.

Stop Use and Ask Doctor If

condition worsens
severe skin irritation occurs
pain persists for more than 7 days
pain clears up and then recurs a few days later

Principal Display Panel 18 G Jar Label

CVS

Health™

INTENSE STRENGTH

Muscle

Balm

PAIN RELIEVING OINTMENT

NET WT 0.63 OZ (18 g)

Principal Display Panel 18 G Carton Label

CVS

Health™

Compare to the active

ingredient in Tiger Balm ^®*

INTENSE STRENGTH

Muscle Balm

PAIN RELIEVING OINTMENT

Relieves pain where it hurts

Temporary muscle pain relief from:

Backaches
Arthritis
Joint pain
Bruises
Strains
Sprains

NET WT 0.63 OZ (18 g)

Structured Label Content

Uses

For temporary relief of minor aches and pains of muscles and joints associated with over-exertion, simple backache, arthritis, strains and sprains.

Section 50565-1 (50565-1)

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

Section 53414-9 (53414-9)

If pregnant or breast feeding, ask a healthcare professional before use

Purpose

Topical analgesic

Warnings

For external use only

Directions

rub on affected area. Repeat 3 to 4 times daily.
for adults and children 12 and over
under 12 consult doctor before use

Other Information (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 and Paraffin Petrolatum

When Using This Product (When using this product)

avoid contact with eyes and mucous membranes
do not apply to open wounds or damaged skin
do not bandage or use heating pad.

Stop Use and Ask Doctor If (Stop use and ask doctor if)

condition worsens
severe skin irritation occurs
pain persists for more than 7 days
pain clears up and then recurs a few days later

Principal Display Panel 18 G Jar Label (Principal Display Panel - 18 g Jar Label)

CVS

Health™

INTENSE STRENGTH

Muscle

Balm

PAIN RELIEVING OINTMENT

NET WT 0.63 OZ (18 g)

Principal Display Panel 18 G Carton Label (Principal Display Panel - 18 g Carton Label)

CVS

Health™

Compare to the active

ingredient in Tiger Balm ^®*

INTENSE STRENGTH

Muscle Balm

PAIN RELIEVING OINTMENT

Relieves pain where it hurts

Temporary muscle pain relief from:

Backaches
Arthritis
Joint pain
Bruises
Strains
Sprains

NET WT 0.63 OZ (18 g)

Advanced Ingredient Data

[{"name": "CAJUPUT OIL", "unii": "J3TO6BUQ37", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "CHINESE CINNAMON OIL", "unii": "A4WO0626T5", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "CLOVE OIL", "unii": "578389D6D0", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "PEPPERMINT OIL TERPENELESS", "unii": "4CA0UO1N3Z", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "PARAFFIN", "unii": "I9O0E3H2ZE", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "PETROLATUM", "unii": "4T6H12BN9U", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "MENTHOL, UNSPECIFIED FORM", "unii": "L7T10EIP3A", "classCode": "ACTIB", "strengthNumerator": "110", "strengthDenominator": "1", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "g"}, {"name": "CAMPHOR (SYNTHETIC)", "unii": "5TJD82A1ET", "classCode": "ACTIB", "strengthNumerator": "110", "strengthDenominator": "1", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "g"}]

Raw Label Data

All Sections (JSON)

{"Uses": "For temporary relief of minor aches and pains of muscles and joints associated with over-exertion, simple backache, arthritis, strains and sprains.", "50565-1": "Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center immediately", "53414-9": "If pregnant or breast feeding , ask a healthcare professional before use", "Purpose": "Topical analgesic Topical analgesic", "Warnings": "For external use only", "Directions": "rub on affected area. Repeat 3 to 4 times daily. for adults and children 12 and over under 12 consult doctor before use", "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 and Paraffin Petrolatum", "When using this product": "avoid contact with eyes and mucous membranes do not apply to open wounds or damaged skin do not bandage or use heating pad.", "Stop use and ask doctor if": "condition worsens severe skin irritation occurs pain persists for more than 7 days pain clears up and then recurs a few days later", "Principal Display Panel - 18 g Jar Label": "CVS Health™ INTENSE STRENGTH Muscle Balm PAIN RELIEVING OINTMENT NET WT 0.63 OZ (18 g)", "Principal Display Panel - 18 g Carton Label": "CVS Health™ Compare to the active ingredient in Tiger Balm ® * INTENSE STRENGTH Muscle Balm PAIN RELIEVING OINTMENT Relieves pain where it hurts Temporary muscle pain relief from: Backaches Arthritis Joint pain Bruises Strains Sprains NET WT 0.63 OZ (18 g)"}

Additional Information

Back to search View SPL set listing Open on DailyMed ↗

Source: dailymed · Ingested: 2026-02-15T12:03:40.834993 · Updated: 2026-03-14T23:03:51.620726