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Blue Ice Topical Analgesic by FOUR SEASONS TRADING INC

Medically reviewed on November 27, 2017

Dosage form: gel
Ingredients: MENTHOL 1g in 100g, CAMPHOR (SYNTHETIC) .5g in 100g
Labeler: FOUR SEASONS TRADING INC
NDC Code: 69274-004

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.

Blue Ice Topical Analgesic Gel

Active Ingredients

Menthol             1.0%

Camphor            0.5%

Purpose

Topical Analgesic

Uses

For the temporary relief of minor pains and aches of your muscles and joints associated with:

  • Sports Injuries
  • Sprains
  • Arthritis
  • Bruises

Warnings

For external use only. Avoid contact with eyes.

Ask a doctor before use if you have cough associated with :

  • smoking
  • excessive phlegm
  • asthma
  • emphysema
  • persistent or chronic cough

When using this product, do not

  • heat
  • microwave
  • add to hot water or any container where heating water may cause splattering and result in burns
  • use in eyes or directly on mucous membranes
  • take by mouth or place in nostrils
  • apply to wounds or damaged skin
  • bandage skin

Do not use with heating devices or pads.

Consult a doctor and discontinue use if condition worsens, persists for more than 1 week or tends to recur.

Keep out of reach of children

In case of accidental ingestion, seek professional assistance or contact a Poison Control Center immediately.

Directions: see important warnings under “When using this product”

adults and children 2 years and over:

  • apply to the affected area not more than 3 to 4 times daily
  • children under 2 years of age: consult a physician.

Inactive Ingredients

Aqua, Isopropyl Alcohol, Propylene Glycol, Carbopol, PEG-40 Hydrogenated Castor Oil, Sodium Hydroxide , Disodium EDTA, Benzyl Alcohol, BHT & FD&C Blue No.1

PRINCIPAL DISPLAY PANEL

BLUE ICE TOPICAL ANALGESIC GEL

NET WT. 8 OZ (227g)


BLUE ICE TOPICAL ANALGESIC 
menthol and camphor gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69274-004
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MENTHOL (MENTHOL) MENTHOL1 g  in 100 g
CAMPHOR (SYNTHETIC) (CAMPHOR (SYNTHETIC)) CAMPHOR (SYNTHETIC).5 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
WATER 
ISOPROPYL ALCOHOL 
PROPYLENE GLYCOL 
CARBOMER HOMOPOLYMER TYPE B (ALLYL SUCROSE CROSSLINKED) 
POLYOXYL 40 HYDROGENATED CASTOR OIL 
SODIUM HYDROXIDE 
EDETATE DISODIUM 
BENZYL ALCOHOL 
BUTYLATED HYDROXYTOLUENE 
FD&C BLUE NO. 1 
Packaging
#Item CodePackage Description
1NDC:69274-004-15127 g in 1 TUBE
2NDC:69274-004-16170 g in 1 TUBE
3NDC:69274-004-13170 g in 1 BOTTLE, PLASTIC
4NDC:69274-004-17227 g in 1 BOTTLE, PLASTIC
5NDC:69274-004-18300 g in 1 BOTTLE, PLASTIC
6NDC:69274-004-19500 g in 1 BOTTLE, PLASTIC
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34811/25/2014
Labeler - FOUR SEASONS TRADING INC (169331464)
Registrant - Anicare Pharmaceuticals Pvt. Ltd (916837425)
Establishment
NameAddressID/FEIOperations
Anicare Pharmaceuticals Pvt. Ltd916837425manufacture(69274-004)

 
FOUR SEASONS TRADING INC

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Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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