SPL v1
SPL
SPL Set ID f5c4c351-2710-3c30-e053-2995a90adeb7
Route
TOPICAL
Published
Effective Date 2023-02-28
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Menthol (4 g)
Inactive Ingredients
Aloe Vera Leaf Hyaluronate Sodium Cyanocobalamin Dimethyl Sulfone Alcohol Arnica Montana Flower Butylene Glycol Cetostearyl Alcohol Phenoxyethanol Carbomer 940 Salix Alba Bark Sorbitol Trolamine Cetyl Alcohol Peppermint Oil Polysorbate 60 Caprylyl Glycol Water

Identifiers & Packaging

Pill Appearance
Color: pink
Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2023-05-03

Description

Menthol, 4%

Purpose

Topical analgesic


Medication Information

Purpose

Topical analgesic

Description

Menthol, 4%

Uses

temporarily relieves minor pain associated with: arthritis simple backache muscle strains sprains bruises cramps

Section 43683-2

effective date update and wording of Directions for Use updated to match label

Section 50565-1

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

Keep out of reach of children . If case of accidental ingestion, get medical help or contact a poison Control Center right away.

Section 50566-9

Stop use and ask a physician if condition worsens or symptoms persist for more than 7 days or clear up and occur again within a few days redness is present irritation develops

Section 50567-7

When using this prodcut use only as directed avoid contact with eyes or mucous membranes •do not apply to wounds or damaged skin •do not bandage tightly

Warnings

For external use only

Directions:

Adults and children 2 years of age and older: apply generously to affected area massage into painful area until thoroughly absorbed into skin repeat as necessary, but no more than 4 time daily

Children under 2 years of age: ask a doctor

Package Label

Active Incredient

Menthol, 4%

Inactive Ingredients

Alcohol, Aloe Barbadensis Leaf Juice, Arnica montana Flower Extract, Butylene Glycol, Caprylyl Glycol, Carbomer, Cetearyl Alcohol, Cetyl Alcohol, Cyanocobalamin, Mentha piperita (Peppermint) Leaf Oil, Methylsulfonylmethane, Phenoxyethanol, Polysorbate-60, Purified Water, Salix alba (Willow) Bark Extract, Sodium Hyaluronate, Sorbitol, Triethanolamine


Structured Label Content

Uses

temporarily relieves minor pain associated with: arthritis simple backache muscle strains sprains bruises cramps

Section 43683-2 (43683-2)

effective date update and wording of Directions for Use updated to match label

Section 50565-1 (50565-1)

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

Keep out of reach of children . If case of accidental ingestion, get medical help or contact a poison Control Center right away.

Section 50566-9 (50566-9)

Stop use and ask a physician if condition worsens or symptoms persist for more than 7 days or clear up and occur again within a few days redness is present irritation develops

Section 50567-7 (50567-7)

When using this prodcut use only as directed avoid contact with eyes or mucous membranes •do not apply to wounds or damaged skin •do not bandage tightly

Purpose

Topical analgesic

Warnings

For external use only

Directions:

Adults and children 2 years of age and older: apply generously to affected area massage into painful area until thoroughly absorbed into skin repeat as necessary, but no more than 4 time daily

Children under 2 years of age: ask a doctor

Package Label

Active Incredient

Menthol, 4%

Inactive Ingredients (Inactive ingredients)

Alcohol, Aloe Barbadensis Leaf Juice, Arnica montana Flower Extract, Butylene Glycol, Caprylyl Glycol, Carbomer, Cetearyl Alcohol, Cetyl Alcohol, Cyanocobalamin, Mentha piperita (Peppermint) Leaf Oil, Methylsulfonylmethane, Phenoxyethanol, Polysorbate-60, Purified Water, Salix alba (Willow) Bark Extract, Sodium Hyaluronate, Sorbitol, Triethanolamine


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)