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

Active Ingredient

Active ingredient

Menthol 1%

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

Structured Label Content

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

Active Ingredient (55106-9)

Active ingredient

Menthol 1%

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.
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

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