Eglemsclerubrllonmthnlmthylslcte

Eglemsclerubrllonmthnlmthylslcte
SPL v4
SPL
SPL Set ID 5e02fbe3-5bc7-430e-b661-3a760ddd8fe0
Route
TOPICAL
Published
Effective Date 2015-06-16
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Menthol (14.5 g) Salicylic Acid (30 g)
Inactive Ingredients
Alcohol Camphor (synthetic) Thymol

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2015-06-15

Description

Menthol 14.5% Methyl Salicylate 30%

Purpose

External Analgesic


Medication Information

Purpose

External Analgesic

Description

Menthol 14.5% Methyl Salicylate 30%

Uses

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

■ bruises ■ sprains

Warnings

■ For external use only ■ Avoid getting into eyes and mucous membranes

Directions

■ adults and children 12 years of age and older apply to affected area not more than 3 to 4 time daily. ■ apply liberally and gently rub into affected area ■ children under 12 years of age, consult a doctor before using.

Package Label

Active Ingredients

Menthol 14.5%

Methyl Salicylate 30%



Inactive Ingredients

alcohol, camphor, thymol

When Using This Product

■ do not apply to wound or damaged skin ■ do not bandage tightly ■ do not use otherwise than as directed

Stop Use and Ask A Doctor If

■ condition worsens, or if symptoms persist for more than 7 days or clear up and occur again within a few days ■ pain persists for more than 10 days ■ redness is present ■ conditions affect children under 12 years of age

Keep This Drug Out of Reach of Children

to avoid accidental poisoning. In case of accidental ingestion, contact a doctor or Poison Control Center immediately. If pregnant or breast-feeding, ask a health professional before use


Structured Label Content

Uses

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

■ bruises ■ sprains

Purpose

External Analgesic

Warnings

■ For external use only ■ Avoid getting into eyes and mucous membranes

Directions

■ adults and children 12 years of age and older apply to affected area not more than 3 to 4 time daily. ■ apply liberally and gently rub into affected area ■ children under 12 years of age, consult a doctor before using.

Package Label

Active Ingredients

Menthol 14.5%

Methyl Salicylate 30%



Inactive Ingredients (Inactive ingredients)

alcohol, camphor, thymol

When Using This Product (When using this product)

■ do not apply to wound or damaged skin ■ do not bandage tightly ■ do not use otherwise than as directed

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

■ condition worsens, or if symptoms persist for more than 7 days or clear up and occur again within a few days ■ pain persists for more than 10 days ■ redness is present ■ conditions affect children under 12 years of age

Keep This Drug Out of Reach of Children (Keep this drug out of reach of children)

to avoid accidental poisoning. In case of accidental ingestion, contact a doctor or Poison Control Center immediately. If pregnant or breast-feeding, ask a health professional before use


Advanced Ingredient Data


Raw Label Data

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