Theracare Ice Blue Gel

Theracare Ice Blue Gel
SPL v3
SPL
SPL Set ID d61eb82f-782b-e08b-e053-2a95a90a10ff
Route
TOPICAL
Published
Effective Date 2022-01-01
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Menthol (20 mg)
Inactive Ingredients
Polyoxyl 40 Hydrogenated Castor Oil Benzyl Alcohol Fd&c Blue No. 1 Ammonia Carbomer 940 Cupric Sulfate Isopropyl Alcohol Magnesium Sulfate, Unspecified Form Sodium Hydroxide Thymol Water

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2022-01-01

Description

Menthol 2%

Purpose

Topical analgesic


Medication Information

Purpose

Topical analgesic

Description

Menthol 2%

Uses

● temporarily relieves minor aches and pains of muscles and joints associated with:

● simple backache

● arthritis

● strains

● bruises

● sprains

Warnings

For external use only

Directions
  • clean affected area before applying product
  • 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: ask a doctor before using this product
Active Ingredient

Menthol 2%

Other Information
  • do not freeze
  • store at room temperature
  • keep container tightly closed when not in use
  • do not use, pour, spill, or store near heat or open flame
Principal Display

Inactive Ingredients

ammonium hydroxide, benzyl alcohol, carbopor 940, cupric sulfate, FD&C blue no. 1, isopropyl alcohol, magnesium sulfate, PEG-40 hydrogenated castor oil, sodium hydroxide, thymol, water

Questions Or Comments?

Customer care 866-326-1313

When Using This Product
  • with other topical pain relievers
  • with heating pads or heating devices
  • avoid contact with eyes
  • do not bandage tightly
  • do not apply to wounds or damage skin
Stop Use and Ask A Doctor If
  • condition worsens or symptoms persist for more than 7 days or clear up and occur again within a few days
If Pregnant Or Breast Feeding

ask a health professional before use

Keep Out of Reach of Children

If swallowed, get medical help or contact a Poison Control Center (800-222-1222) right away.


Structured Label Content

Uses

● temporarily relieves minor aches and pains of muscles and joints associated with:

● simple backache

● arthritis

● strains

● bruises

● sprains

Purpose

Topical analgesic

Warnings

For external use only

Directions
  • clean affected area before applying product
  • 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: ask a doctor before using this product
Active Ingredient (Active ingredient)

Menthol 2%

Other Information (Other information)
  • do not freeze
  • store at room temperature
  • keep container tightly closed when not in use
  • do not use, pour, spill, or store near heat or open flame
Principal Display

Inactive Ingredients (Inactive ingredients)

ammonium hydroxide, benzyl alcohol, carbopor 940, cupric sulfate, FD&C blue no. 1, isopropyl alcohol, magnesium sulfate, PEG-40 hydrogenated castor oil, sodium hydroxide, thymol, water

Questions Or Comments? (Questions or comments?)

Customer care 866-326-1313

When Using This Product (When Using this product)
  • with other topical pain relievers
  • with heating pads or heating devices
  • avoid contact with eyes
  • do not bandage tightly
  • do not apply to wounds or damage skin
Stop Use and Ask A Doctor If (Stop use and ask a doctor if)
  • condition worsens or symptoms persist for more than 7 days or clear up and occur again within a few days
If Pregnant Or Breast Feeding (If pregnant or breast-feeding)

ask a health professional before use

Keep Out of Reach of Children

If swallowed, get medical help or contact a Poison Control Center (800-222-1222) right away.


Advanced Ingredient Data


Raw Label Data

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