Refreshing External Analgesic Oil

Refreshing External Analgesic Oil
SPL v6
SPL
SPL Set ID c62a4313-2c07-5f58-e053-2995a90a083a
Route
TOPICAL
Published
Effective Date 2021-07-02
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Salicylic Acid (15 g) Menthol (14 g)
Inactive Ingredients
Clove Oil Light Mineral Oil Eucalyptus Oil

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2021-06-30

Description

Menthol 14% Methyl Salicylate 15%

Purpose

External Analgesic External Analgesic


Medication Information

Purpose

External Analgesic

External Analgesic

Description

Menthol 14% Methyl Salicylate 15%

Uses

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

Warnings

For external use only

Directions

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

Package Label

Active Ingredients

Menthol 14%

Methyl Salicylate 15%

Inactive Ingredients

clove oil, eucalyptus oil, fragrance, light mineral oil

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 tha 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 to avoid accidental poisoning. In case of accidental ingestion contact a doctor or Poison Control Center immediately


Structured Label Content

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

Warnings

For external use only

Directions

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

Package Label

Active Ingredients

Menthol 14%

Methyl Salicylate 15%

Inactive Ingredients

clove oil, eucalyptus oil, fragrance, light mineral oil

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 tha 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 to avoid accidental poisoning. In case of accidental ingestion contact a doctor or Poison Control Center immediately


Advanced Ingredient Data


Raw Label Data

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