Rite Aid Cool Therapy Gel

Rite Aid Cool Therapy Gel
SPL v2
SPL
SPL Set ID dfed135a-b55e-93d6-e053-2a95a90a90d6
Route
TOPICAL
Published
Effective Date 2022-05-01
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

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

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2022-05-01

Description

Menthol 4%

Purpose

Topical Analgesic


Medication Information

Purpose

Topical Analgesic

Description

Menthol 4%

Uses

Temporary relief from minor aches and pains of sore muscles and joints associated with arthritis, backache, strains, sprains

Warnings

For external use only

Directions

Adults and children 2 years of age and older: Rub a thin film over affected areas not more than 4 times daily; massage not necessary



Children under 2 years of age: Consult physician

Flammable:

Keep away from excessive heat or open flame.

Package Labeling:

Active Ingredients

Menthol 4%

Inactive Ingredients

benzyl alcohol, butylated hydroxy tolune, 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

Questions Or Comments

1-866-326-1313 Monday- Friday 8:30am-4:30 pm CST

When Using This Product:

Avoid contact with the 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 irritated develops; Do not bandage; Wash hands after use with cool water; Do not use with a heating pad or device

Stop Use and Ask A Doctor If:

Condition worsens, or if symptoms persist for more than 7 days, or clear up and reoccur

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 (1-800-222-1222) right away.

Ask A Doctor Before Use If You Have:

Sensitive skin


Structured Label Content

Uses

Temporary relief from minor aches and pains of sore muscles and joints associated with arthritis, backache, strains, sprains

Purpose

Topical Analgesic

Warnings

For external use only

Directions

Adults and children 2 years of age and older: Rub a thin film over affected areas not more than 4 times daily; massage not necessary



Children under 2 years of age: Consult physician

Flammable:

Keep away from excessive heat or open flame.

Package Labeling:

Active Ingredients

Menthol 4%

Inactive Ingredients

benzyl alcohol, butylated hydroxy tolune, 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

Questions Or Comments (Questions or Comments)

1-866-326-1313 Monday- Friday 8:30am-4:30 pm CST

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

Avoid contact with the 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 irritated develops; Do not bandage; Wash hands after use with cool water; Do not use with a heating pad or device

Stop Use and Ask A Doctor If: (Stop use and ask a doctor if:)

Condition worsens, or if symptoms persist for more than 7 days, or clear up and reoccur

If Pregnant Or Breast Feeding: (If pregnant or breast-feeding:)

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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