SPL v3
SPL
SPL Set ID 83366ae1-e1d9-2a30-e053-2a91aa0a1cc4
Route
TOPICAL
Published
Effective Date 2019-01-21
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Menthol (4 g)
Inactive Ingredients
Adansonia Digitata Seed Oil Arnica Montana Calendula Officinalis Flower Carboxypolymethylene Citric Acid Monohydrate Dimethyl Sulfone Alcohol Methyl Glucose Dioleate Sodium Hydroxide Water

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2019-01-21

Description

Menthol USP 4%


Medication Information

Warnings and Precautions

Use only as directed.

For external use only.Keep away from excessive heat or flame.

Indications and Usage

For the temporary relief of minor aches and pains of muscles and joints associated with

  • simple backache
  • arthritis
  • strains
  • bruises
  • sprains
Dosage and Administration

Adults and children 2 years of age and older:

  • Apply to affected area not more than 3 to 4 times daily.

Children under 2 years of age:

  • Consult physician.
Description

Menthol USP 4%

Section 44425-7
  • Store in a cool, dry place.
  • Avoid direct sunlight.
  • Tamper-evident for your protection. Use only if safety seal is intact.
  • Keep away from excessive heat or flame.
Section 50565-1

Keep out of reach of children. If accidentally ingested, get medical help or contact Poison Control Center immediately.

Section 50566-9

Stop use and ask doctor if:

  • Condition worsens
  • Symptoms persist for more than 7 days, or clear up and occur again within a few days
Section 50567-7

When using this product:

  • Avoid contact with eyes and mucous membranes
  • Do not apply to wounds or damaged skin
  • Do not bandage or use with a heating pad, other ointments, creams, sprays, or liniments
Section 51727-6

Purified Water, Ethyl Alcohol, Dimethyl Sulfone (MSM), Arnica Montana, Calendula Officinalis Flower Extract, Methyl Glucose Dioleate, Sodium Hydroxide, Baobab Oil, Carbomer, Citric Acid

Section 51945-4

Section 53413-1

888-819-6472

Monday - Friday, 9am - 5pm CT

Report any serious side effects to number above.

Section 53414-9

If pregnant or breastfeeding:Ask a health professional before using.

Section 55105-1

Menthol USP 4% ........................... Topical Analgesic

Section 55106-9

Menthol USP 4%


Structured Label Content

Indications and Usage (34067-9)

For the temporary relief of minor aches and pains of muscles and joints associated with

  • simple backache
  • arthritis
  • strains
  • bruises
  • sprains
Dosage and Administration (34068-7)

Adults and children 2 years of age and older:

  • Apply to affected area not more than 3 to 4 times daily.

Children under 2 years of age:

  • Consult physician.
Warnings and Precautions (34071-1)

Use only as directed.

For external use only.Keep away from excessive heat or flame.

Section 44425-7 (44425-7)
  • Store in a cool, dry place.
  • Avoid direct sunlight.
  • Tamper-evident for your protection. Use only if safety seal is intact.
  • Keep away from excessive heat or flame.
Section 50565-1 (50565-1)

Keep out of reach of children. If accidentally ingested, get medical help or contact Poison Control Center immediately.

Section 50566-9 (50566-9)

Stop use and ask doctor if:

  • Condition worsens
  • Symptoms persist for more than 7 days, or clear up and occur again within a few days
Section 50567-7 (50567-7)

When using this product:

  • Avoid contact with eyes and mucous membranes
  • Do not apply to wounds or damaged skin
  • Do not bandage or use with a heating pad, other ointments, creams, sprays, or liniments
Section 51727-6 (51727-6)

Purified Water, Ethyl Alcohol, Dimethyl Sulfone (MSM), Arnica Montana, Calendula Officinalis Flower Extract, Methyl Glucose Dioleate, Sodium Hydroxide, Baobab Oil, Carbomer, Citric Acid

Section 51945-4 (51945-4)

Section 53413-1 (53413-1)

888-819-6472

Monday - Friday, 9am - 5pm CT

Report any serious side effects to number above.

Section 53414-9 (53414-9)

If pregnant or breastfeeding:Ask a health professional before using.

Section 55105-1 (55105-1)

Menthol USP 4% ........................... Topical Analgesic

Section 55106-9 (55106-9)

Menthol USP 4%


Advanced Ingredient Data


Raw Label Data

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