1441 Extreme Freeze Ndc 67777-144-10

1441 Extreme Freeze Ndc 67777-144-10
SPL v6
SPL
SPL Set ID 79f0802f-03ad-bf8f-e053-2991aa0ae4b5
Route
TOPICAL
Published
Effective Date 2018-08-17
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Menthol (4 g)
Inactive Ingredients
Isopropyl Myristate Trolamine Carboxypolymethylene Aloe Vera Leaf Glycerin Isopropyl Alcohol Arnica Montana Flower Frankincense Calendula Officinalis Flower Ilex Paraguariensis Leaf Melissa Officinalis Leaf Arctium Lappa Root Green Tea Leaf Alpha-tocopherol Acetate Silicon Dioxide .alpha.,.alpha.-dibromo-d-camphor Fd&c Yellow No. 5 Water Fd&c Blue No. 1

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2018-08-17
Description

Menthol USP 4% Active

Purpose

Cooling Pain Relief

Medication Information

Purpose

Cooling Pain Relief

Description

Menthol USP 4% Active

Use(s)

• Temporary relief from minor aches and pains of sore muscles and joints associated with arthritis, backache, strains, and sprains

• Provides penetrating pain relief

Warnings

For External Use Only

1441 Label

1442 Label

1444 Label

1447 Label

Directions
  • Adults and children 2 years of age or older: Apply to affected area not more than 3 to 4 times daily.
  • Children under 2 years of age: Do not use, consult a doctor.
Questions?

1-888-DYNAREX Monday-Friday, 9AM-5PM EST

Active Ingredient

Menthol USP 4% Active

Other Information

• Store in a cool dry place

• Tamper evident. Do not use if seal is damaged.

Inactive Ingredients

Aloe Barbadensis Leaf Extract, Arctium Lappa Root Extract, Arnica Montana Flower Extract, Boswellia Certerii Resin Extract, Brilliant Blue, Calendula Officinalis Extract, Camellia Sinensis Leaf Extract (Green Tea Leaf), Camphor, Carbomer, Glycerin, Llex Paraguariensis Leaf Extract, Isopropyl Alcohol, Isopropyl Myristate, Melissa Officinalis Leaf Extract, Purified Water, Silicon Dioxide, Tartrazine, Tocopheryl Acetate, Triethanolamine

When Using This Product

• Avoid contact with eyes

• Do not apply to wounds or damaged skin

• Do not bandage tightly

Keep Out of Reach of Children

If swallowed, get medical help. Contact a physician or Poison Control Center (1-800-222-1222) right way.

Stop Use and Ask A Doctor If:

• Condition worsens

• Symptoms last more than 7 days or clear up and occur again within a few days, discontinue use of this product

If Pregnant Or Breast Feeding:

Ask a health professional before use.

Structured Label Content

Use(s)

• Temporary relief from minor aches and pains of sore muscles and joints associated with arthritis, backache, strains, and sprains

• Provides penetrating pain relief

Purpose

Cooling Pain Relief

Warnings

For External Use Only

1441 Label

1442 Label

1444 Label

1447 Label

Directions
  • Adults and children 2 years of age or older: Apply to affected area not more than 3 to 4 times daily.
  • Children under 2 years of age: Do not use, consult a doctor.
Questions?

1-888-DYNAREX Monday-Friday, 9AM-5PM EST

Active Ingredient

Menthol USP 4% Active

Other Information

• Store in a cool dry place

• Tamper evident. Do not use if seal is damaged.

Inactive Ingredients

Aloe Barbadensis Leaf Extract, Arctium Lappa Root Extract, Arnica Montana Flower Extract, Boswellia Certerii Resin Extract, Brilliant Blue, Calendula Officinalis Extract, Camellia Sinensis Leaf Extract (Green Tea Leaf), Camphor, Carbomer, Glycerin, Llex Paraguariensis Leaf Extract, Isopropyl Alcohol, Isopropyl Myristate, Melissa Officinalis Leaf Extract, Purified Water, Silicon Dioxide, Tartrazine, Tocopheryl Acetate, Triethanolamine

When Using This Product (When using this product)

• Avoid contact with eyes

• Do not apply to wounds or damaged skin

• Do not bandage tightly

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

If swallowed, get medical help. Contact a physician or Poison Control Center (1-800-222-1222) right way.

Stop Use and Ask A Doctor If: (Stop use and ask a doctor if:)

• Condition worsens

• Symptoms last more than 7 days or clear up and occur again within a few days, discontinue use of this product

If Pregnant Or Breast Feeding: (If pregnant or breast feeding:)

Ask a health professional before use.

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:08:20.375989 · Updated: 2026-03-14T23:12:32.924893