External Analgesic

External Analgesic
SPL v5
SPL
SPL Set ID 3b6155a5-51aa-2780-e054-00144ff8d46c
Route
TOPICAL
Published
Effective Date 2016-08-31
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Camphor (synthetic) (96 mg) Capsaicin (0.5 mg) Menthol (78 mg)
Inactive Ingredients
Aluminum Hydroxide Glycerin Methyl Acrylate Tartaric Acid Water Capsicum

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2016-08-25

Description

Camphor 9.6% Capsaicin 0.05% Menthol 7.8%

Purpose

External Analgesic


Medication Information

Purpose

External Analgesic

Description

Camphor 9.6% Capsaicin 0.05% Menthol 7.8%

Uses

For the temporary relief of minor aches and pains of muscles and joints associated with

-simple backache

-arthritis

-strains

-bruises

-sprains

Label

Warnings

When using this product

-avoid contact with the eyes

- do not apply to wounds or damaged skin

-do not bandage tightly

Stop use and ask a doctor if

- condition worsens

-if synthoms oersust for more than 7 days or clear up and occur again within a few days

If pregnant or breast-feeding, ask a health professional before use.

Directions

Adults and children 12 years of age and older:

-Clean and dry affected area.

-Remove from backing film and apply.

-Remove from the skin after at most 8 hours' application.

-Apply to the affected area not more than 3 times daily.

-Children under 12 years of age: Consult a doctor.

Active Ingredients

Camphor 9.6%

Capsaicin 0.05%

Menthol 7.8%

Inactive Ingredients

Acrylic Acid, Aluminum Hydroxide, Carmellose Sodium, 2-ethylhexylacrylate, Glycerin, Methyl Acrylate, Polyacrylate, polyacrylic Acid, sodium polyacrylatem, Tartaric Acid, Water.

Keep Out of Reach of Children.

If Swallowed, get medical help or contact a Poison Control Center right away.


Structured Label Content

Uses

For the temporary relief of minor aches and pains of muscles and joints associated with

-simple backache

-arthritis

-strains

-bruises

-sprains

Label

Purpose

External Analgesic

Warnings

When using this product

-avoid contact with the eyes

- do not apply to wounds or damaged skin

-do not bandage tightly

Stop use and ask a doctor if

- condition worsens

-if synthoms oersust for more than 7 days or clear up and occur again within a few days

If pregnant or breast-feeding, ask a health professional before use.

Directions

Adults and children 12 years of age and older:

-Clean and dry affected area.

-Remove from backing film and apply.

-Remove from the skin after at most 8 hours' application.

-Apply to the affected area not more than 3 times daily.

-Children under 12 years of age: Consult a doctor.

Active Ingredients (Active ingredients)

Camphor 9.6%

Capsaicin 0.05%

Menthol 7.8%

Inactive Ingredients (Inactive ingredients)

Acrylic Acid, Aluminum Hydroxide, Carmellose Sodium, 2-ethylhexylacrylate, Glycerin, Methyl Acrylate, Polyacrylate, polyacrylic Acid, sodium polyacrylatem, Tartaric Acid, Water.

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

If Swallowed, get medical help or contact a Poison Control Center right away.


Advanced Ingredient Data


Raw Label Data

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