Drug Facts

Drug Facts
SPL v4
SPL
SPL Set ID 888f88fc-dcaf-93e5-e053-2a95a90a20e1
Route
TOPICAL
Published
Effective Date 2019-05-03
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Capsaicin (0.15 g) Menthol (13.5 g) Salicylic Acid (30 g)
Inactive Ingredients
Eucalyptol Paraffin Petrolatum

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2010-05-14

Description

Capsaicin 0.15% Menthol 13.5% Methyl Salicylate 30%

Purpose

External Analgesic External Analgesic External Analgesic


Medication Information

Purpose

External Analgesic

External Analgesic

External Analgesic

Description

Capsaicin 0.15% Menthol 13.5% Methyl Salicylate 30%

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

■ Avoid getting into the eyes or on mucus membranes.

Directions

■ Adults and children 12 years of age and over: Apply to affected area not more than 3 to 4 time daily ■ Children under 12 years of age:consult a doctor



Package Label

20g NDC: 60954-001-01

Active Ingredients

Capsaicin 0.15%

Menthol 13.5%

Methyl Salicylate 30%



Inactive Ingredients

eucalyptol, fragrance, paraffin wax and petroleum jelly

When Using This Product

■ do not apply to wound or damaged skin ■ ​do not bandage tightly ■ do not use if excessive irritation of the skin develops

■ 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 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

External Analgesic

Warnings

■ For external use only

■ Avoid getting into the eyes or on mucus membranes.

Directions

■ Adults and children 12 years of age and over: Apply to affected area not more than 3 to 4 time daily ■ Children under 12 years of age:consult a doctor



Package Label

20g NDC: 60954-001-01

Active Ingredients

Capsaicin 0.15%

Menthol 13.5%

Methyl Salicylate 30%



Inactive Ingredients

eucalyptol, fragrance, paraffin wax and petroleum jelly

When Using This Product (When using this product)

■ do not apply to wound or damaged skin ■ ​do not bandage tightly ■ do not use if excessive irritation of the skin develops

■ 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 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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