REXALL ICE COLD ANALGESIC- menthol gel 
Dolgencorp, LLC

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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Active ingredient

Menthol 2%

Purpose


Topical Analgesic

Uses

For the temporary relief of monor aches and pains in muscles and joints associated with:


■ simple backache
■ sprains

■ arthritis

■ strains

■ sports injuries

■ bruises

Warnings

For external use only

Do not use

■ with other topical pain relievers

■ with heating pads or heating devices

When using this product

■ do not use in or near eyes ■ do not apply to wounds or damaged skin ■ do not bandage tightly

Stop use and ask a doctor if

■ condition worsens ■ symptoms last for more than 7 days or clear up and occur again within a few days ■ redness or irritation develops

If pregnant or breast-feeding

ask a health professional before use

Keep out of reach of children

Keep out of reach of children and pets. If swallowed, get medical help or contact a Poison Control Center right away.

Directions

■ clean affected area before applying product ■ adults and children 2 years of age and older: apply to affected area not more than 3 to 4 times daily

Inactive Ingredients

ammonium hydroxide, carbomer, cupric sulphate, FD&C blue no. 1, isopropyl alcohol, magnesium sulphate, sodium hydroxide, thymol, water

Package Label

Package Label

REXALL ICE COLD ANALGESIC 
menthol gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55910-088
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL2 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
CARBOXYPOLYMETHYLENE (UNII: 0A5MM307FC)  
CUPRIC SULFATE (UNII: LRX7AJ16DT)  
MAGNESIUM SULFATE, UNSPECIFIED (UNII: DE08037SAB)  
THYMOL (UNII: 3J50XA376E)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
ISOPROPYL ALCOHOL (UNII: ND2M416302)  
SODIUM HYDROXIDE (UNII: 55X04QC32I)  
WATER (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:55910-088-08227 g in 1 JAR; Type 0: Not a Combination Product10/01/2018
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34810/01/2018
Labeler - Dolgencorp, LLC (068331990)

Revised: 10/2018
Document Id: 7769fdbb-be39-7fc6-e053-2991aa0aa088
Set id: 7769ca14-3159-4bfa-e053-2a91aa0a65f1
Version: 1
Effective Time: 20181004
 
Dolgencorp, LLC