Blue Ice Gel

Blue Ice Gel

Drug Labeling and Warnings

Drug Details

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BLUE ICE ANALGESIC- menthol gel 
Delon Laboratories (1990) Ltd

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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Blue Ice Gel

Active ingredient


Menthol 2.0%

Purpose

Topical analgesic

Uses

  • for the temporarily relief of minor aches and pains of muscles and joints

Warnings

For external use only

When using this product

  • do not heat
  • avoid contact with the eyes
  • do not apply to wounds or damaged skin
  • do not bandage tightly

Stop use and ask a doctor if

  • condition worsens
  • symptoms persist for more than 7 days or clear up and occur again within a few days
  • skin irritation develops

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 right away.

Directions

  • adults and children 2 years of age and older: apply to affected area not more than 3 to 4 times daily
  • children under 2 years of age: consult a doctor

Inactive ingredients

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

Delon 8oz (227g)

label

Penetro 227g

Penetro Blue Ice Analgesic Gel

BLUE ICE ANALGESIC 
menthol gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 61734-021
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
THYMOL (UNII: 3J50XA376E)  
AMMONIA (UNII: 5138Q19F1X)  
SODIUM HYDROXIDE (UNII: 55X04QC32I)  
MAGNESIUM SULFATE HEPTAHYDRATE (UNII: SK47B8698T)  
CARBOMER 934 (UNII: Z135WT9208)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
WATER (UNII: 059QF0KO0R)  
ISOPROPYL ALCOHOL (UNII: ND2M416302)  
Product Characteristics
ColorblueScore    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 61734-021-01100 g in 1 BOTTLE, PUMP; Type 0: Not a Combination Product05/07/201011/06/2017
2NDC: 61734-021-02113.56 g in 1 CONTAINER; Type 0: Not a Combination Product05/07/201012/04/2014
3NDC: 61734-021-03227 g in 1 CONTAINER; Type 0: Not a Combination Product05/07/2010
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34805/07/2010
Labeler - Delon Laboratories (1990) Ltd (248364184)
Establishment
NameAddressID/FEIBusiness Operations
Delon Laboratories (1990) Inc.243387722manufacture(61734-021) , pack(61734-021) , label(61734-021)

Revised: 10/2018
 
Delon Laboratories (1990) Ltd


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