81683-003

81683-003
SPL v3
SPL
SPL Set ID bd4fdff1-9174-31c2-e053-2a95a90a749f
Route
TOPICAL
Published
Effective Date 2021-03-18
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Menthol (8.3 g)
Inactive Ingredients
Ilex Paraguariensis Leaf Arctium Lappa Root Chamomile Flower Oil Green Tea Leaf Carbomer 940 Aloe Vera Leaf Camphor Oil Isopropyl Myristate Maltodextrin Water Glycerin Trolamine Arnica Montana Flower Alcohol

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2021-03-18

Description

Menthol6%

Purpose

Topical Analgesic


Medication Information

Purpose

Topical Analgesic

Description

Menthol6%

Uses:

Provides soothing cold to sore muscles and joints.

Section 50569-3

Consult a doctor and discontinue use if irritation occurs.

Ask a health professional before use if pregnant or breastfeeding.

Ask a doctor before using if you have sensitive skin.

Section 50570-1

Do not use otherwise than as directed.

Section 51945-4

Warnings:

For external use only. Avoid contact with eyes, mucous membrane or broken skin.

Directions:

Apply liberally to area of pain and massage until lotion is absorbed into the skin. Repeat 3-4 times daily. Store at 68° to 77 ℉(20° to 25℃).

Active Ingredient

Menthol6%

Inactive Ingredients:

Aloe Barbadensis(Aloe Vera) Leaf Juice, Arctium Lappa(Burdock)Root Extract, Arnica Montana Flower Extract, Carbomer, Chamomilla Recutita (Matricaria) Flower Water, Camellia Sinensis(Green Tea) Leaf Extract, Cinnamomum Camphora Bark Oil, Ethyl Alcohol, Glycerin, Isopropyl Myristate, Ilex Paraguariensis Leaf Extract, Maltodextrin, Triethanolamine, Water

Keep Out of Reach of Children:

In case of accidental ingestion, get medical help or call Poison Control Center right away. Not for children 5 years or younger.

When Using This Product, Do Not:

heat, microwave, add to hot water or any container where heating water may cause splattering and result in burns, use in eyes or directly on mucus membrane, take by mouth or place in nostrils, apply to wounds or damaged skin.


Structured Label Content

Uses: (USES:)

Provides soothing cold to sore muscles and joints.

Section 50569-3 (50569-3)

Consult a doctor and discontinue use if irritation occurs.

Ask a health professional before use if pregnant or breastfeeding.

Ask a doctor before using if you have sensitive skin.

Section 50570-1 (50570-1)

Do not use otherwise than as directed.

Section 51945-4 (51945-4)

Purpose (PURPOSE)

Topical Analgesic

Warnings: (WARNINGS:)

For external use only. Avoid contact with eyes, mucous membrane or broken skin.

Directions: (DIRECTIONS:)

Apply liberally to area of pain and massage until lotion is absorbed into the skin. Repeat 3-4 times daily. Store at 68° to 77 ℉(20° to 25℃).

Active Ingredient (ACTIVE INGREDIENT)

Menthol6%

Inactive Ingredients: (INACTIVE INGREDIENTS:)

Aloe Barbadensis(Aloe Vera) Leaf Juice, Arctium Lappa(Burdock)Root Extract, Arnica Montana Flower Extract, Carbomer, Chamomilla Recutita (Matricaria) Flower Water, Camellia Sinensis(Green Tea) Leaf Extract, Cinnamomum Camphora Bark Oil, Ethyl Alcohol, Glycerin, Isopropyl Myristate, Ilex Paraguariensis Leaf Extract, Maltodextrin, Triethanolamine, Water

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

In case of accidental ingestion, get medical help or call Poison Control Center right away. Not for children 5 years or younger.

When Using This Product, Do Not: (When using this product, do not:)

heat, microwave, add to hot water or any container where heating water may cause splattering and result in burns, use in eyes or directly on mucus membrane, take by mouth or place in nostrils, apply to wounds or damaged skin.


Advanced Ingredient Data


Raw Label Data

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