Pain Relief Balm Ointment

Pain Relief Balm Ointment
SPL v2
SPL
SPL Set ID 12d76b8f-4b1d-4f2d-9722-0adb55093cc4
Route
TOPICAL
Published
Effective Date 2025-10-07
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Menthol (110 mg) Camphor (synthetic)
Inactive Ingredients
Cajuput Oil Chinese Cinnamon Oil Clove Oil Peppermint Oil Paraffin

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-10-07
Description

Camphor 11%...................................................Topical analgesic Menthol 11%....................................................Topical analgesic

Purpose

Camphor 11%...................................................Topical analgesic Menthol 11%....................................................Topical analgesic

Medication Information

Purpose

Camphor 11%...................................................Topical analgesic Menthol 11%....................................................Topical analgesic

Description

Camphor 11%...................................................Topical analgesic Menthol 11%....................................................Topical analgesic

Uses
  • For temporary relief of minor aches and pains of muscles and joints associated with simple backache, arthritis, bruises, strains and sprains
Section 50565-1

Keep out of reach of children.If swallowed, get medical help or contact a Poison Control Center right away (1-800-222-1222).

Section 53414-9

If pregnant or breast-feeding, or if you have sensitive skin, ask a healthcare professional before use

Warnings

For external use only

Directions

Adults and children 12 years of age and older

Apply to affected area not more than 3 to 4 times daily

Children under 12 years of age

Consult a doctor before use

Children under 2 years of age

Do not use
Questions?

Call XXX-XXX-XXXX

Other Information
  • This product may cause allergic reaction on some individuals. Test on a small area before use.
  • Do not use if printed seal is broken or missing
  • Recommended storage temperature below 86°F (30°C). Store in a cool, dry place.
Inactive Ingredients

Cajuput Oil, Cassia Oil, Clove Oil, Dementholized Mint Oil, Paraffin Base

Principal Display Panel

Pain Relief Balm Ointment 0.5 oz (14.2g) - NDC 73492-718-15 - Container Label

Pain Relief Balm Ointment 0.5 oz (14.2g) - NDC 73492-718-15 - Carton Label

When Using This Product
  • use only as directed
  • avoid contact with eyes & mucous membranes
  • do not apply to wounds, damaged, or irritated skin
  • do not bandage or cover with wrap or use heating pad
  • do not use 1 hour prior to bathing or within 30 minutes after bathing
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
Active Ingredients                                                purpose

Camphor 11%...................................................Topical analgesic

Menthol 11%....................................................Topical analgesic

Structured Label Content

Uses
  • For temporary relief of minor aches and pains of muscles and joints associated with simple backache, arthritis, bruises, 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 right away (1-800-222-1222).

Section 53414-9 (53414-9)

If pregnant or breast-feeding, or if you have sensitive skin, ask a healthcare professional before use

Warnings

For external use only

Directions

Adults and children 12 years of age and older

Apply to affected area not more than 3 to 4 times daily

Children under 12 years of age

Consult a doctor before use

Children under 2 years of age

Do not use
Questions?

Call XXX-XXX-XXXX

Other Information (Other information)
  • This product may cause allergic reaction on some individuals. Test on a small area before use.
  • Do not use if printed seal is broken or missing
  • Recommended storage temperature below 86°F (30°C). Store in a cool, dry place.
Inactive Ingredients (Inactive ingredients)

Cajuput Oil, Cassia Oil, Clove Oil, Dementholized Mint Oil, Paraffin Base

Principal Display Panel (PRINCIPAL DISPLAY PANEL)

Pain Relief Balm Ointment 0.5 oz (14.2g) - NDC 73492-718-15 - Container Label

Pain Relief Balm Ointment 0.5 oz (14.2g) - NDC 73492-718-15 - Carton Label

When Using This Product (When using this product)
  • use only as directed
  • avoid contact with eyes & mucous membranes
  • do not apply to wounds, damaged, or irritated skin
  • do not bandage or cover with wrap or use heating pad
  • do not use 1 hour prior to bathing or within 30 minutes after bathing
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
Active Ingredients                                                purpose (Active Ingredients                                                Purpose)

Camphor 11%...................................................Topical analgesic

Menthol 11%....................................................Topical analgesic

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:07:31.658109 · Updated: 2026-03-14T23:11:05.615438