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NDC 11822-4217-01 Rite Aid Cool Therapy Gel 40 mg/mL Details

Rite Aid Cool Therapy Gel 40 mg/mL

Rite Aid Cool Therapy Gel is a TOPICAL GEL in the HUMAN OTC DRUG category. It is labeled and distributed by Rite Aid. The primary component is MENTHOL.

Product Information

NDC	11822-4217
Product ID	11822-4217_dfed13d5-8af0-7f07-e053-2a95a90a389e
Associated GPIs
GCN Sequence Number	n/a
GCN Sequence Number Description	n/a
HIC3	n/a
HIC3 Description	n/a
GCN	n/a
HICL Sequence Number	n/a
HICL Sequence Number Description	n/a
Brand/Generic	n/a
Proprietary Name	Rite Aid Cool Therapy Gel
Proprietary Name Suffix	n/a
Non-Proprietary Name	MENTHOL
Product Type	HUMAN OTC DRUG
Dosage Form	GEL
Route	TOPICAL
Active Ingredient Strength	40
Active Ingredient Units	mg/mL
Substance Name	MENTHOL
Labeler Name	Rite Aid
Pharmaceutical Class	n/a
DEA Schedule	n/a
Marketing Category	OTC MONOGRAPH NOT FINAL
Application Number	part348
Listing Certified Through	2023-12-31

Package

Package Images

NDC 11822-4217-01 (11822421701)

Pricing Information	N/A
NDC Package Code	11822-4217-1
Billing NDC	11822421701
Package	88.72 mL in 1 BOTTLE (11822-4217-1)
Marketing Start Date	2022-05-01
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL dfed135a-b55e-93d6-e053-2a95a90a90d6 Details

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:

INGREDIENTS AND APPEARANCE

RITE AID COOL THERAPY GEL

menthol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:11822-4217
Route of Administration	TOPICAL

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

Ingredient Name	Strength
Inactive Ingredients
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)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:11822-4217-1	88.72 mL in 1 BOTTLE; Type 0: Not a Combination Product	05/01/2022

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part348	05/01/2022

Labeler - Rite Aid (014578892)

Name	Address	ID/FEI	Business Operations
Establishment
Anicare Pharmaceuticals Pvt. Ltd.		916837425	manufacture(11822-4217)

Revised: 5/2022

Document Id: dfed13d5-8af0-7f07-e053-2a95a90a389e

Set id: dfed135a-b55e-93d6-e053-2a95a90a90d6

Version: 1

Effective Time: 20220526