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SPL v4
SPL
SPL Set ID 6f7a796b-a31c-0e60-e053-2a91aa0a022b
Route
topical
Published
Effective Date 2018-06-25
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
camphor (synthetic) (11 g) menthol (15 g)
Inactive Ingredients
peppermint oil paraffin petrolatum

Identifiers & Packaging

Marketing Status
otc monograph drug active Since 2018-05-14
Purpose

External Analgesic External Analgesic

Description

Menthol 15% Camphor 11%

Medication Information

Warnings

For External Use Only

Uses

For the temporary relief of minor pains and aches of muscles and joints associated with ■ simple backache ■arthritis ■strains ■bruises ■sprains

Purpose

External Analgesic

External Analgesic

Directions

■ Adults and children 12 years of age: apply to affected area not more than 3 - 4 times daily. ■ children under 12 years of age, consult a doctor before use

Other Information

■ Store in a cool dry place

Inactive Ingredients

fragrance, paraffin, peppermint oil, petrolatum

Description

Menthol 15% Camphor 11%

Package Label

Active Ingredients

Menthol 15%

Camphor 11%

When Using This Product

■ Avoid getting into the eyes or on mucous membranes ■ do not apply to wounds and damaged skin ■ do not bandage tightly or use with a heating pad ■ do not use otherwise than as directed

Stop Use and Ask A Doctor If

■ Condition worsens, ■ symptoms persist for more than 7 days or clear up and occur again within a few days ■ redness is present

Keep Out of Reach of Children

Keep out of reach of children in case of accidental ingestion contact a doctor or Poison Control Center immediately

Structured Label Content

Warnings

For External Use Only

Uses

For the temporary relief of minor pains and aches of muscles and joints associated with ■ simple backache ■arthritis ■strains ■bruises ■sprains

Purpose

External Analgesic

External Analgesic

Directions

■ Adults and children 12 years of age: apply to affected area not more than 3 - 4 times daily. ■ children under 12 years of age, consult a doctor before use

Other Information

■ Store in a cool dry place

Inactive Ingredients

fragrance, paraffin, peppermint oil, petrolatum

Package Label

Active Ingredients

Menthol 15%

Camphor 11%

When Using This Product (When using this product)

■ Avoid getting into the eyes or on mucous membranes ■ do not apply to wounds and damaged skin ■ do not bandage tightly or use with a heating pad ■ do not use otherwise than as directed

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

■ Condition worsens, ■ symptoms persist for more than 7 days or clear up and occur again within a few days ■ redness is present

Keep Out of Reach of Children (Keep out of reach of children)

Keep out of reach of children in case of accidental ingestion contact a doctor or Poison Control Center immediately

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:04:14.318826 · Updated: 2026-03-14T23:04:49.494867