Hielo Ardiente

Hielo Ardiente
SPL v4
SPL
SPL Set ID 97ec516c-d2bc-47ce-82fe-bd68445d9570
Route
TOPICAL
Published
Effective Date 2021-04-15
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Menthol (1 g)
Inactive Ingredients
Camphor (synthetic) Carbomer 940 Fd&c Blue No. 1 Isopropyl Alcohol Methylchloroisothiazolinone Methylisothiazolinone Polysorbate 20 Water Triethanolamine Benzoate

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2012-02-21
Description

Active ingredient Menthol 1%

Medication Information

Warnings and Precautions

Warnings

For external use only

  • Avoid contact with eyes
  • Do not use if condition worsens
  • If symptoms persist for more than 5 days or recur, discontinue use and consult a physician
  • Do not apply to open wounds or damaged skin
  • Do not bandage tightly
  • Do not use with heating pads or heating devices

Use only as directed

Indications and Usage

Uses

For the temporary relief of minor aches and pains of muscles and joints associated with simple backaches, arthritis, strains, bruises and sprains.

Dosage and Administration

Directions

  • Adults and children 12 years of age or older:Apply to affected area no more than 3 to 4 times daily. Children under 12 years of age, consult a physician
  • Cleanse and dry skin. May be used with wet or dry bandages in conjuction with ice packs.
Description

Active ingredient Menthol 1%

Section 50565-1

Keep out of reach of children.

In case of accidental ingestion, contact a doctor or a Poison Control Center right away.

Section 51727-6

Inactive ingredients

camphor, carbomer 940, FD&C blue #1, isopropyl alcohol, methylchloroisothiazolinone, methylisothiazolinone, polysorbate 20, purified water, triethanolamine

Section 51945-4

Section 55105-1

Purpose

Analgesic

Section 55106-9

Active ingredient

Menthol 1%

Structured Label Content

Indications and Usage (34067-9)

Uses

For the temporary relief of minor aches and pains of muscles and joints associated with simple backaches, arthritis, strains, bruises and sprains.

Dosage and Administration (34068-7)

Directions

  • Adults and children 12 years of age or older:Apply to affected area no more than 3 to 4 times daily. Children under 12 years of age, consult a physician
  • Cleanse and dry skin. May be used with wet or dry bandages in conjuction with ice packs.
Warnings and Precautions (34071-1)

Warnings

For external use only

  • Avoid contact with eyes
  • Do not use if condition worsens
  • If symptoms persist for more than 5 days or recur, discontinue use and consult a physician
  • Do not apply to open wounds or damaged skin
  • Do not bandage tightly
  • Do not use with heating pads or heating devices

Use only as directed

Section 50565-1 (50565-1)

Keep out of reach of children.

In case of accidental ingestion, contact a doctor or a Poison Control Center right away.

Section 51727-6 (51727-6)

Inactive ingredients

camphor, carbomer 940, FD&C blue #1, isopropyl alcohol, methylchloroisothiazolinone, methylisothiazolinone, polysorbate 20, purified water, triethanolamine

Section 51945-4 (51945-4)

Section 55105-1 (55105-1)

Purpose

Analgesic

Section 55106-9 (55106-9)

Active ingredient

Menthol 1%

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:06:35.839826 · Updated: 2026-03-14T23:09:28.158875