Quality Choice Cold Therapy Gel, 4oz

Quality Choice Cold Therapy Gel, 4oz
SPL v4
SPL
SPL Set ID f9c659cd-e7fa-ac2d-e053-6294a90a2573
Route
TOPICAL
Published
Effective Date 2023-04-01
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Menthol (40 mg)
Inactive Ingredients
Camphor (natural) Carbomer 940 Benzyl Alcohol Isopropyl Alcohol Edetate Disodium Polyoxyl 40 Hydrogenated Castor Oil Butylated Hydroxytoluene Water Dmdm Hydantoin Sodium Hydroxide Fd&c Blue No. 1 Fd&c Yellow No. 5

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2023-04-01

Description

For external use only Flammable: Keep away from excessive heat or open flame

Purpose

Topical analgesic


Medication Information

Purpose

Topical analgesic

Description

For external use only Flammable: Keep away from excessive heat or open flame

Uses

Temporarily relieves minor aches and pains of muscles and joints associated with:

  • arthritis
  • backache
  • strains
  • sprains
Section 51945-4

Warnings

For external use only

Flammable: Keep away from excessive heat or open flame

Directions

adults and children 2 years of age and older:

  • rub a thin film over affected area not more than 4 times daily, massage is not necessary

children under 2 years of age: consult a physician

Other Info

■ store in a cool dry place

■ do not use if tube seal under cap is broken

Active Ingredient

Menthol 4%

Inactive Ingredients

Inactive ingredients

benzyl alcohol, butylated hydroxytoluene, camphor, carbopol 940, edetate disodium, DMDM hydantoin, FD&C blue no. 1, FD&C yellow no. 5,isopropyl alcohol, PEG-40 hydrogenated castor oil, sodium hydroxide, water

When Using This Product:

■ avoid contact with eyes or mucous membranes

■ do not apply to wounds or damaged skin

■ do not use with other ointments, creams, sprays or liniments

■ do not apply to irritated skin or if excessive irritation develops

■ do not bandage ■ wash hands after use with cool water

■ do not use with a heating pad or device

Stop Use An Ask A Doctor If

condition worsens, if symptoms last more than 7 days or clear up and reoccur

If Pregnant Or Breastfeeding:

ask a health professional before use

Keep Out of Reach of Children.

If swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) right away

Ask A Doctor Before Use If You Have:

sensitive skin


Structured Label Content

Uses

Temporarily relieves minor aches and pains of muscles and joints associated with:

  • arthritis
  • backache
  • strains
  • sprains
Section 51945-4 (51945-4)

Purpose

Topical analgesic

Warnings

For external use only

Flammable: Keep away from excessive heat or open flame

Directions

adults and children 2 years of age and older:

  • rub a thin film over affected area not more than 4 times daily, massage is not necessary

children under 2 years of age: consult a physician

Other Info

■ store in a cool dry place

■ do not use if tube seal under cap is broken

Active Ingredient (Active ingredient)

Menthol 4%

Inactive Ingredients

Inactive ingredients

benzyl alcohol, butylated hydroxytoluene, camphor, carbopol 940, edetate disodium, DMDM hydantoin, FD&C blue no. 1, FD&C yellow no. 5,isopropyl alcohol, PEG-40 hydrogenated castor oil, sodium hydroxide, water

When Using This Product: (When using this product:)

■ avoid contact with eyes or mucous membranes

■ do not apply to wounds or damaged skin

■ do not use with other ointments, creams, sprays or liniments

■ do not apply to irritated skin or if excessive irritation develops

■ do not bandage ■ wash hands after use with cool water

■ do not use with a heating pad or device

Stop Use An Ask A Doctor If (Stop use an ask a doctor if)

condition worsens, if symptoms last more than 7 days or clear up and reoccur

If Pregnant Or Breastfeeding: (If pregnant or breastfeeding:)

ask a health professional before use

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

If swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) right away

Ask A Doctor Before Use If You Have: (Ask a doctor before use if you have:)

sensitive skin


Advanced Ingredient Data


Raw Label Data

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