RITE AID COOL THERAPY GEL- menthol gel 
Rite Aid

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Rite Aid Cool Therapy Gel

Drug Facts

Active Ingredients

Menthol 4%

Purpose

Topical Analgesic

Uses

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

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 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.

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

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

Package Labeling:

label

RITE AID COOL THERAPY GEL 
menthol gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:11822-4217
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL40 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
BENZYL ALCOHOL (UNII: LKG8494WBH)  
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
CAMPHOR (NATURAL) (UNII: N20HL7Q941)  
CARBOMER 940 (UNII: 4Q93RCW27E)  
EDETATE DISODIUM (UNII: 7FLD91C86K)  
DMDM HYDANTOIN (UNII: BYR0546TOW)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
ISOPROPYL ALCOHOL (UNII: ND2M416302)  
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
POLYOXYL 40 HYDROGENATED CASTOR OIL (UNII: 7YC686GQ8F)  
SODIUM HYDROXIDE (UNII: 55X04QC32I)  
WATER (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:11822-4217-188.72 mL in 1 BOTTLE; Type 0: Not a Combination Product05/01/2022
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34805/01/2022
Labeler - Rite Aid (014578892)
Establishment
NameAddressID/FEIBusiness Operations
Anicare Pharmaceuticals Pvt. Ltd.916837425manufacture(11822-4217)

Revised: 5/2022
Document Id: dfed13d5-8af0-7f07-e053-2a95a90a389e
Set id: dfed135a-b55e-93d6-e053-2a95a90a90d6
Version: 1
Effective Time: 20220526
 
Rite Aid