COOL HOT ICE ANALGESIC GEL- menthol gel 
SHIELD LINE 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.

----------

Active Ingredient

Menthol 1.0%

Purpose

Topical Analgesic

Uses:

Warnings

FOR EXTERNAL USE ONLY

Use only as directed. Avoid contact with eyes or mucous membranes. Do not apply to open wounds or damaged skin. Make sure skin is clean and free from any creams , ointments , sprays or liniment. Do not bandage.

Do not use with heating pads or heating devices

If condition worsens or symptoms persist for more than 7 days, or if symptoms disappear and occur again within a few days, discontinue use and consult a physician before use. If skin irritation develops, discontinue use and consult a physician. If you are pregnant or nursing a baby, consult your doctor before use. Do not use, store, pour or spoll near heat or open flame. Store in a cool, dry place and keep lid tightly closed.

In case of accidental ingestion, get medical help or contact a Poison Control Center right away

Directions

Clean skin of all other lotions, creams, ointments, liniment, or sprays. Apply liberally to affected area and massage until gel is absorbed into skin. Do not apply more than 3 or 4 times daily. No protective cover needed. Do not apply to children under 2 years or age.

Inactive Ingredients

Water, Isopropyl Alchohol , Nonoxynol-10, Camphor, Carbomer 934, Sodium Hydroxide, Methylchloroisothiazolinone & Methylisothiazolinone, FD&C Blue no. 1

package label

COOL HOT ICE ANALGESIC GEL 
menthol gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:52410-0201
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL2.27 g  in 227 g
Inactive Ingredients
Ingredient NameStrength
ISOPROPYL ALCOHOL (UNII: ND2M416302)  
NONOXYNOL-10 (UNII: K7O76887AP)  
CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET)  
CARBOMER 934 (UNII: Z135WT9208)  
SODIUM HYDROXIDE (UNII: 55X04QC32I)  
METHYLCHLOROISOTHIAZOLINONE (UNII: DEL7T5QRPN)  
METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
WATER (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:52410-0201-2227 g in 1 JAR; Type 0: Not a Combination Product09/21/2009
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34109/21/2009
Labeler - SHIELD LINE LLC (078518916)

Revised: 5/2019
Document Id: 89a5a583-e8a5-5ae6-e053-2a95a90aa348
Set id: 35d523ac-85df-3a92-e054-00144ff8d46c
Version: 2
Effective Time: 20190524
 
SHIELD LINE LLC