THERACARE ICE BLUE GEL PAIN RELIEVING- menthol gel 
Veridian Healthcare

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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Theracare Ice Blue Gel

Active ingredient

Menthol 2%

Purpose

Topical analgesic

Uses

● temporarily relieves minor aches and pains of muscles and joints associated with:

● simple backache

● arthritis

● strains

● bruises

● sprains

Warnings

For external use only

When Using this product

Stop use and ask a doctor if

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 (800-222-1222) right away.

Directions

Other information

Inactive ingredients

ammonium hydroxide, benzyl alcohol, carbopor 940, cupric sulfate, FD&C blue no. 1, isopropyl alcohol, magnesium sulfate, PEG-40 hydrogenated castor oil, sodium hydroxide, thymol, water

Questions or comments?

Customer care 866-326-1313

Principal Display

label

THERACARE ICE BLUE GEL  PAIN RELIEVING
menthol gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71101-217
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL20 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
POLYOXYL 40 HYDROGENATED CASTOR OIL (UNII: 7YC686GQ8F)  
BENZYL ALCOHOL (UNII: LKG8494WBH)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
AMMONIA (UNII: 5138Q19F1X)  
CARBOMER 940 (UNII: 4Q93RCW27E)  
CUPRIC SULFATE (UNII: LRX7AJ16DT)  
ISOPROPYL ALCOHOL (UNII: ND2M416302)  
MAGNESIUM SULFATE, UNSPECIFIED FORM (UNII: DE08037SAB)  
SODIUM HYDROXIDE (UNII: 55X04QC32I)  
THYMOL (UNII: 3J50XA376E)  
WATER (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:71101-217-01226.8 g in 1 JAR; Type 0: Not a Combination Product01/01/2022
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34801/01/2022
Labeler - Veridian Healthcare (830437997)
Establishment
NameAddressID/FEIBusiness Operations
ANICARE PHARMACEUTICALS PRIVATE LIMITED916837425manufacture(71101-217)

Revised: 5/2023
Document Id: fc714ed3-86f4-5cc3-e053-6394a90a34d9
Set id: d61eb82f-782b-e08b-e053-2a95a90a10ff
Version: 2
Effective Time: 20230524
 
Veridian Healthcare