SPL v2
SPL
SPL Set ID 35d523ac-85df-3a92-e054-00144ff8d46c
Route
TOPICAL
Published
Effective Date 2016-06-21
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Menthol (2.27 g)
Inactive Ingredients
Isopropyl Alcohol Nonoxynol-10 Camphor (synthetic) Carbomer 934 Sodium Hydroxide Methylchloroisothiazolinone Methylisothiazolinone Fd&c Blue No. 1 Water

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH FINAL Active Since 2009-09-21

Description

Menthol 1.0%

Purpose

Topical Analgesic


Medication Information

Purpose

Topical Analgesic

Description

Menthol 1.0%

Uses
  • temporary relief of minor aches and pains in muscles and joints associated with simple backaches, strains, sprains, arthritis and sports injuries
Section 50565-1

In case of accidental ingestion, get medical help or contact a Poison Control Center right away

Section 51945-4

Warnings

FOR EXTERNAL USE ONLY

Use only as directed. Avoid contact with eyes or mucous membranes. Do not apply to open wounds or damaged skin. Make sure skin is clean and free from any creams , ointments , sprays or liniment. Do not bandage.

Directions

Clean skin of all other lotions, creams, ointments, liniment, or sprays. Apply liberally to affected area and massage until gel is absorbed into skin. Do not apply more than 3 or 4 times daily. No protective cover needed. Do not apply to children under 2 years or age.

Active Ingredient

Menthol 1.0%

Inactive Ingredients

Water, Isopropyl Alchohol , Nonoxynol-10, Camphor, Carbomer 934, Sodium Hydroxide, Methylchloroisothiazolinone & Methylisothiazolinone, FD&C Blue no. 1

Do Not Use With Heating Pads Or Heating Devices

If condition worsens or symptoms persist for more than 7 days, or if symptoms disappear and occur again within a few days, discontinue use and consult a physician before use. If skin irritation develops, discontinue use and consult a physician. If you are pregnant or nursing a baby, consult your doctor before use. Do not use, store, pour or spoll near heat or open flame. Store in a cool, dry place and keep lid tightly closed.


Structured Label Content

Uses
  • temporary relief of minor aches and pains in muscles and joints associated with simple backaches, strains, sprains, arthritis and sports injuries
Section 50565-1 (50565-1)

In case of accidental ingestion, get medical help or contact a Poison Control Center right away

Section 51945-4 (51945-4)

Purpose

Topical Analgesic

Warnings

FOR EXTERNAL USE ONLY

Use only as directed. Avoid contact with eyes or mucous membranes. Do not apply to open wounds or damaged skin. Make sure skin is clean and free from any creams , ointments , sprays or liniment. Do not bandage.

Directions

Clean skin of all other lotions, creams, ointments, liniment, or sprays. Apply liberally to affected area and massage until gel is absorbed into skin. Do not apply more than 3 or 4 times daily. No protective cover needed. Do not apply to children under 2 years or age.

Active Ingredient

Menthol 1.0%

Inactive Ingredients

Water, Isopropyl Alchohol , Nonoxynol-10, Camphor, Carbomer 934, Sodium Hydroxide, Methylchloroisothiazolinone & Methylisothiazolinone, FD&C Blue no. 1

Do Not Use With Heating Pads Or Heating Devices (Do not use with heating pads or heating devices)

If condition worsens or symptoms persist for more than 7 days, or if symptoms disappear and occur again within a few days, discontinue use and consult a physician before use. If skin irritation develops, discontinue use and consult a physician. If you are pregnant or nursing a baby, consult your doctor before use. Do not use, store, pour or spoll near heat or open flame. Store in a cool, dry place and keep lid tightly closed.


Advanced Ingredient Data


Raw Label Data

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