SPL v1
SPL
SPL Set ID d7876228-8dd7-e3bd-e053-2a95a90a7925
Route
TOPICAL
Published
Effective Date 2022-02-08
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Menthol (3 g)
Inactive Ingredients
Capsicum Emu Oil Aloe Vera Leaf Arnica Montana Flower Coriander Oil Tilia Cordata Flower Dehydrated Alcohol Hamamelis Virginiana Top Hypericum Perforatum Dimethyl Sulfone Salix Alba Bark Edetate Sodium Tetrahydrate Chamaemelum Nobile Flower Caprylyl Glycol Carbomer 940 Centaurea Cyanus Flower Cetostearyl Alcohol Chamomile Phenoxyethanol Butylene Glycol Water Trolamine Calendula Officinalis Flower Sorbitol

Identifiers & Packaging

Pill Appearance
Color: white
Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2022-02-08

Description

Menthol, 3.0%

Purpose

Topical analgesic


Medication Information

Purpose

Topical analgesic

Description

Menthol, 3.0%

Uses

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

Section 43683-2

typographical correction and effective date update

Section 50565-1

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

Keep out of reach of children. If swallowed, get medical help or contact Poison Control Center right away.

Section 50566-9

Stop use and ask a doctor if condition worsens 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 do not bandage tightly or use with heating pad avoid contact with eyes or mucous membranes •do not apply to wounds or damaged skin

Warnings

for external use only

Directions:

Adults and children over 12 years: 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 12 years or younger: ask a doctor

Package Label

Active Incredient

Menthol, 3.0%

Inactive Ingredients

Aloe Barbadensis Leaf Juice, Anthemis nobilis (Roman Chamomile), Arnica montana Flower Extract, Butylene Glycol, Calendula officinalis (Marigold), Caprylyl Glycol, Capsicum frutescens Fruit, Carbomer, Centaurea cyanus (Cornflower), Cetearyl Alcohol, Chamomilla recutita (Matricaria Chamomilla), Coriandrum sativum (Coriander) Fruit Oil, Emu Oil, Fragrance, Hamamelis virginiana (Witch Hazel) Bark/Leaf/Twig Extract, Hypericum perforatum (St. John's Wort), Methylsulfonylmethane, Phenoxyethanol, Purified Water, Salix alba (Willow) Bark Extract, SD Alcohol 40, Sorbitol, Tetrasodium EDTA, Tilia cordata (Lime Tree), Triethanolamine.


Structured Label Content

Uses

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

Section 43683-2 (43683-2)

typographical correction and effective date update

Section 50565-1 (50565-1)

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

Keep out of reach of children. If swallowed, get medical help or contact Poison Control Center right away.

Section 50566-9 (50566-9)

Stop use and ask a doctor if condition worsens 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 do not bandage tightly or use with heating pad avoid contact with eyes or mucous membranes •do not apply to wounds or damaged skin

Purpose

Topical analgesic

Warnings

for external use only

Directions:

Adults and children over 12 years: 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 12 years or younger: ask a doctor

Package Label

Active Incredient

Menthol, 3.0%

Inactive Ingredients (Inactive ingredients)

Aloe Barbadensis Leaf Juice, Anthemis nobilis (Roman Chamomile), Arnica montana Flower Extract, Butylene Glycol, Calendula officinalis (Marigold), Caprylyl Glycol, Capsicum frutescens Fruit, Carbomer, Centaurea cyanus (Cornflower), Cetearyl Alcohol, Chamomilla recutita (Matricaria Chamomilla), Coriandrum sativum (Coriander) Fruit Oil, Emu Oil, Fragrance, Hamamelis virginiana (Witch Hazel) Bark/Leaf/Twig Extract, Hypericum perforatum (St. John's Wort), Methylsulfonylmethane, Phenoxyethanol, Purified Water, Salix alba (Willow) Bark Extract, SD Alcohol 40, Sorbitol, Tetrasodium EDTA, Tilia cordata (Lime Tree), Triethanolamine.


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)