QUALITY CHOICE COLD THERAPY GEL- menthol gel

Quality Choice Cold Therapy Gel by

Drug Labeling and Warnings

Quality Choice Cold Therapy Gel by is a Otc medication manufactured, distributed, or labeled by Chain Drug Marketing Association, Inc., ANICARE PHARMACEUTICALS PRIVATE LIMITED. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Warnings

For external use only

Flammable: Keep away from excessive heat or open flame

Ask a doctor before use if you have:

sensitive skin

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

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

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

Uses

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

• arthritis
• backache
• strains
• sprains

Active ingredient

Menthol 4%

Purpose

Topical analgesic

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

QUALITY CHOICE COLD THERAPY GEL 
menthol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 83324-007
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL	40 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
CAMPHOR (NATURAL) (UNII: N20HL7Q941)
CARBOMER 940 (UNII: 4Q93RCW27E)
BENZYL ALCOHOL (UNII: LKG8494WBH)
ISOPROPYL ALCOHOL (UNII: ND2M416302)
EDETATE DISODIUM (UNII: 7FLD91C86K)
POLYOXYL 40 HYDROGENATED CASTOR OIL (UNII: 7YC686GQ8F)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
WATER (UNII: 059QF0KO0R)
DMDM HYDANTOIN (UNII: BYR0546TOW)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 83324-007-04	118.2 mL in 1 BOTTLE; Type 0: Not a Combination Product	04/01/2023

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M017	04/01/2023

Labeler - Chain Drug Marketing Association, Inc. (011920774)

Establishment
Name	Address	ID/FEI	Business Operations
Astonea Labs Private Label		878533295	manufacture(83324-007)