SPL v2
SPL
SPL Set ID 619c8e3f-0cad-4eb1-8dbb-632f3db74ba3
Route
TOPICAL
Published
Effective Date 2018-05-01
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Menthol (2 g)
Inactive Ingredients
Camphor (synthetic) Propylene Glycol Isopropyl Alcohol Sodium Hydroxide Carbomer Homopolymer Type C Fd&c Blue No. 1 Water

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2017-11-04

Description

Active Ingredients                                                      Purpose Menthol 2%..................................................External Pain Reliever

Purpose

External Pain Reliever


Medication Information

Purpose

External Pain Reliever

Description

Active Ingredients                                                      Purpose Menthol 2%..................................................External Pain Reliever

Uses

Temporarily relief of minor pains of muscles and joints associated with - simple back ache - arthritis - sprains, strains, or bruises

Warnings

Warnings

For external use only.  Avoid contact with eyes

Directions

-Adult and children 2 years of age and older.  Clean skin thoroughly.  Apply liberally to affected area no more than 3-4 times daily.  No protective cover needed.

-May be used with ice packs

-May be used with wet or dry bandages, but wrap loosely

-Children under 2 years of age, consult a doctor

Do Not Use

Do not use - internally - with heating pad or devices - on wounds or damaged skin

Product Label

Active Ingredient

Active Ingredients                                                      Purpose

Menthol 2%..................................................External Pain Reliever

Other Information

Other information store between 59o - 86oF (15o - 30oC)

Keep tightly closed

Do not use, pour, spill, or store near heat or open flame

Other Ingredients

Camphor, Carbomer 940, FDC Blue #1, Isopropyl alcohol, Propylene glycol, Purified water, Sodium hydroxide

Ask A Doctor Before Use

Ask doctor before use if you have sensitive skin

When Using This Product

When using this product - Use only as directed - do not bandage tightly - avoid contact with eyes and mucus membranes

If Pregnant Or Breast Feeding

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

Keep Out of Reach of Children

Keep out of reach of children.  In case of accidental ingestion, get medical help or contact a Poison Control Center immediately.


Structured Label Content

Uses

Temporarily relief of minor pains of muscles and joints associated with - simple back ache - arthritis - sprains, strains, or bruises

Purpose

External Pain Reliever

Warnings

Warnings

For external use only.  Avoid contact with eyes

Directions

-Adult and children 2 years of age and older.  Clean skin thoroughly.  Apply liberally to affected area no more than 3-4 times daily.  No protective cover needed.

-May be used with ice packs

-May be used with wet or dry bandages, but wrap loosely

-Children under 2 years of age, consult a doctor

Do Not Use (Do not use)

Do not use - internally - with heating pad or devices - on wounds or damaged skin

Product Label

Active Ingredient

Active Ingredients                                                      Purpose

Menthol 2%..................................................External Pain Reliever

Other Information (Other information)

Other information store between 59o - 86oF (15o - 30oC)

Keep tightly closed

Do not use, pour, spill, or store near heat or open flame

Other Ingredients (Other ingredients)

Camphor, Carbomer 940, FDC Blue #1, Isopropyl alcohol, Propylene glycol, Purified water, Sodium hydroxide

Ask A Doctor Before Use (Ask a doctor before use)

Ask doctor before use if you have sensitive skin

When Using This Product (When using this product)

When using this product - Use only as directed - do not bandage tightly - avoid contact with eyes and mucus membranes

If Pregnant Or Breast Feeding (If pregnant or breast-feeding)

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

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

Keep out of reach of children.  In case of accidental ingestion, get medical help or contact a Poison Control Center immediately.


Advanced Ingredient Data


Raw Label Data

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