84214-003

84214-003
SPL v1
SPL
SPL Set ID 1d0bf4f9-6b02-6cec-e063-6294a90a36c7
Route
TOPICAL
Published
Effective Date 2024-07-12
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Camphor (natural) (11 g) Menthol (16 g)
Inactive Ingredients
Green Tea Leaf Ilex Paraguariensis Leaf Isopropyl Myristate Echinacea Angustifolia Alcohol Caryophyllene Water Arnica Montana Flower Calendula Officinalis Flower Chamomile Citrus Fruit Dimethyl Sulfoxide Juniper Berry Salix Alba Bark

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2024-07-12

Description

Menthol 16% Camphor 11%

Purpose

Topical Anesthetic


Medication Information

Purpose

Topical Anesthetic

Description

Menthol 16% Camphor 11%

Use

Temporary relief from minor aches and pains of muscles and joints associated with arthritis, simple backache, strains and sprains

Stop Use

if condition worsens, or if symptoms persist for more than 7 days, or clear up and reoccur again within a few days

Warnings

For external use only

Questions

Call 1(888)778-2986

Ask Doctor

if condition worsens, or if symptoms persist for more than 7 days, or clear up and reoccur again within a few days

Directions

·Adults and children 12 years of age and older:Apply to affected area not more than 3 to 4 times daily

·Children under 12 years of age:Consult physician

Do Not Use

While smoking or near heat or open flame

When Using

·avoid contact with the eyes or mucous membranes

·do not apply to wounds or damaged skin

·do not apply to irritated skin

·do not bandage

·wash hands after use with cool water

·do not use with heating pad or device

·spray product away from nose,eyes,and mouth

Active Ingredient

Menthol 16%

Camphor 11%

Inactive Ingredients

Alcohol Denat, Arnica Montana Flower Extract, Beta-Caryophyllene(Clove), Calendula Officinalis Flower, Chamomile Extract, Chorus Fruit Extract,Dimethyl Sulfoxide, Echinacea Angustifolia Extract, Green Tea Extract,IIex Paraguariensis Leaf Extract, Isopropyl Myristate, Juniperus Communis Fruit Extract, Water, White Willow Bark Extract, Oil of Wintergreen.

Principal Display Panel

Keep Oot of Reach of Children

If accidentally ingested get medical help or contact a Poison Control Center immediately. Make sure to turn child safety spray lock to off position when not in use.


Structured Label Content

Use

Temporary relief from minor aches and pains of muscles and joints associated with arthritis, simple backache, strains and sprains

Purpose

Topical Anesthetic

Stop Use

if condition worsens, or if symptoms persist for more than 7 days, or clear up and reoccur again within a few days

Warnings

For external use only

Questions

Call 1(888)778-2986

Ask Doctor

if condition worsens, or if symptoms persist for more than 7 days, or clear up and reoccur again within a few days

Directions

·Adults and children 12 years of age and older:Apply to affected area not more than 3 to 4 times daily

·Children under 12 years of age:Consult physician

Do Not Use (Do not use)

While smoking or near heat or open flame

When Using

·avoid contact with the eyes or mucous membranes

·do not apply to wounds or damaged skin

·do not apply to irritated skin

·do not bandage

·wash hands after use with cool water

·do not use with heating pad or device

·spray product away from nose,eyes,and mouth

Active Ingredient

Menthol 16%

Camphor 11%

Inactive Ingredients (Inactive ingredients)

Alcohol Denat, Arnica Montana Flower Extract, Beta-Caryophyllene(Clove), Calendula Officinalis Flower, Chamomile Extract, Chorus Fruit Extract,Dimethyl Sulfoxide, Echinacea Angustifolia Extract, Green Tea Extract,IIex Paraguariensis Leaf Extract, Isopropyl Myristate, Juniperus Communis Fruit Extract, Water, White Willow Bark Extract, Oil of Wintergreen.

Principal Display Panel (PRINCIPAL DISPLAY PANEL)

Keep Oot of Reach of Children (Keep Oot Of Reach Of Children)

If accidentally ingested get medical help or contact a Poison Control Center immediately. Make sure to turn child safety spray lock to off position when not in use.


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)