SPL v9
SPL
SPL Set ID d38f3099-d940-44d8-aa7f-404157c5e0e3
Route
TOPICAL
Published
Effective Date 2014-11-20
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Menthol (3 g)
Inactive Ingredients
Camphor (natural) Carbomer Copolymer Type A (allyl Pentaerythritol Crosslinked) Alcohol Fd&c Blue No. 1 Isopropyl Alcohol Methylchloroisothiazolinone Methylisothiazolinone Sodium Hydroxide Water

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2014-01-30
Description

Active Ingredients:                                  Purpose Menthol 1.25% ........................... Topical Analgesic

Medication Information

Warnings and Precautions

Warnings

For external use only. Avoid contact with eyes.

Ask a doctor before use if you have cough associated with

  • smoking
  • excessive phlegm
  • asthma
  • emphysema
  • persistent or chronic cough

When using this product do not

  • heat
  • microwave
  • add to hot water or any container where heating water may cause splattering and result in burns
  • use in eyes or directly on mucous membranes
  • take by mouth or place in nostrils
  • apply to wounds or damaged skin
  • bandage skin

Consult a doctor and discontinue use if condition worsens, persists for more than 1 week or tends to recur.

Indications and Usage

XtraCare® Ice Cold Topical Analgesic Gel

Net Wt 8 oz (227 g)

Dosage and Administration

Directions

  • see important warnings under "When using this product"
  • adults & children 2 years of age & older: apply to the affected area not more than 3 to 4 times daily.
  • children under 2 years of age: consult a physician
Description

Active Ingredients:                                  Purpose Menthol 1.25% ........................... Topical Analgesic

Section 50565-1

Keep out of reach of children. In case of accidental ingestion, seek professional assistance or contact a Poison Control Center immediately.

Section 51727-6

Inactive Ingredients:

camphor, carbomer, ethyl alcohol, FD&C blue no.1, isopropyl alcohol, methylchloroisothiazolinone, methylisothiazolinone, sodium hydroxide, water.

Section 51945-4

Section 55105-1

Uses

for the temporary relief of minor aches and pains of muscles and joints.

Section 55106-9

Active Ingredients:                                  Purpose

Menthol 1.25% ........................... Topical Analgesic

Section 60561-8

Other information:  store at 20o to 25oC (68o to 77oF)

Questions/Comments?  1-855-345-5575

DISTRIBUTED BY:

REJOICE INTERNATIONAL INC

NORTHVILLE, MI 48168 USA

MADE IN CHINA

Structured Label Content

Indications and Usage (34067-9)

XtraCare® Ice Cold Topical Analgesic Gel

Net Wt 8 oz (227 g)

Dosage and Administration (34068-7)

Directions

  • see important warnings under "When using this product"
  • adults & children 2 years of age & older: apply to the affected area not more than 3 to 4 times daily.
  • children under 2 years of age: consult a physician
Warnings and Precautions (34071-1)

Warnings

For external use only. Avoid contact with eyes.

Ask a doctor before use if you have cough associated with

  • smoking
  • excessive phlegm
  • asthma
  • emphysema
  • persistent or chronic cough

When using this product do not

  • heat
  • microwave
  • add to hot water or any container where heating water may cause splattering and result in burns
  • use in eyes or directly on mucous membranes
  • take by mouth or place in nostrils
  • apply to wounds or damaged skin
  • bandage skin

Consult a doctor and discontinue use if condition worsens, persists for more than 1 week or tends to recur.

Section 50565-1 (50565-1)

Keep out of reach of children. In case of accidental ingestion, seek professional assistance or contact a Poison Control Center immediately.

Section 51727-6 (51727-6)

Inactive Ingredients:

camphor, carbomer, ethyl alcohol, FD&C blue no.1, isopropyl alcohol, methylchloroisothiazolinone, methylisothiazolinone, sodium hydroxide, water.

Section 51945-4 (51945-4)

Section 55105-1 (55105-1)

Uses

for the temporary relief of minor aches and pains of muscles and joints.

Section 55106-9 (55106-9)

Active Ingredients:                                  Purpose

Menthol 1.25% ........................... Topical Analgesic

Section 60561-8 (60561-8)

Other information:  store at 20o to 25oC (68o to 77oF)

Questions/Comments?  1-855-345-5575

DISTRIBUTED BY:

REJOICE INTERNATIONAL INC

NORTHVILLE, MI 48168 USA

MADE IN CHINA

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:01:42.634815 · Updated: 2026-03-14T23:01:30.191020