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
Purpose

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

Description

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

Medication Information

Warnings

For external use only

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

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

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
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

Description

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

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

Questions?

Call XXX-XXX-XXXX

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

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

Warnings

For external use only

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

Questions?

Call XXX-XXX-XXXX

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

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