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Blue Ice Analgesic Gel

Dosage form: gel
Ingredients: MENTHOL 2.0g in 100g
Labeler: Select Brand Distributors
NDC Code: 15127-452

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.

Drug Facts

Active Ingredient


Menthol 2.0%

Uses

  • Temporary relief of minor aches and pains in: muscles and joints.

Directions

Directions:

  • See important warnings under ''When Using This Product''.
  • Do not apply to children under 2 years of age, unless advised by a physician.
  • Adults and children over 2 years of age and older: Apply liberally to painful area and massage until gel is absorbed into skin. Repeat no more than 3-4 times daily.

Warnings
  • For external use only.
  • Avoid contact with eyes and mucus membranes.

When using this product, do not:

  • use with heating pads or heating devices
  • use, pour, spill or store near open flame
  • use with other creams, sprays or liniments
  • apply to damaged skin or wounds
  • bandage area tightly

To do so may result in excessive skin irritation or skin burn.

If condition worsens, or if symptoms persist for more than 7 days or clear up and occur again within a few days, discontinue use of this product and consult a physician. If you have sensitive skin consult a physician. If skin irritation develops, discontinue use and seek the advice of a physician before using this product.

Purpose
  • Analgesic.

INACTIVE INGREDIENTS

INACTIVE INGREDIENTS: WATER, ISOPROPYL ALCOHOL, CARBOMER, THYMOL, AMMONIUM HYDROXIDE, SODIUM HYDROXIDE, MAGNESIUM SULFATE, FD&C BLUE 1.

Keep out of reach of children
  • In case of accidental ingestion, get medical help or contact a Poison Control Center right away.
BLUE ICE ANALGESIC GEL 
menthol gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:15127-452
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MENTHOL (MENTHOL) MENTHOL2.0 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
WATER88.05 g  in 100 g
ISOPROPYL ALCOHOL8.91 g  in 100 g
CARBOMER HOMOPOLYMER TYPE C0.667 g  in 100 g
THYMOL0.2 g  in 100 g
AMMONIA0.06 g  in 100 g
SODIUM HYDROXIDE0.1 g  in 100 g
MAGNESIUM SULFATE0.01 g  in 100 g
FD&C BLUE NO. 10.003 g  in 100 g
Packaging
#Item CodePackage Description
1NDC:15127-452-08227 g in 1 JAR
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34810/06/2014
Labeler - Select Brand Distributors (043562370)
Establishment
NameAddressID/FEIOperations
Delon Laboratories (1990) Ltd243387722label(15127-452), manufacture(15127-452), pack(15127-452)

Revised: 10/2014
 
Select Brand Distributors

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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