BLUE ICE FERMENTED COD LIVER OIL CALM BALM- camphor, menthol, eucalyptus oil rub salve 
ABS Corporation

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 Fermented Cod Liver Oil Calm Balm

ACTIVE INGREDIENTS:

 Active Ingredients​ Purpose
Camphor (2.63%) Topical Analgesic              
Eucalyptus Oil (3.5%) Topical Analgesic
Menthol (0.74%) Topical Analgesic

PURPOSE:

 Active Ingredients

Purpose

Camphor (2.63%)

 Topical Analgesic               
Eucalyptus Oil (3.5%) Topical Analgesic

Menthol (0.74%)

 Topical Analgesic

Keep Out of Reach of Children.

If swallowed, get medical help or contact Poison Control Center right away.

Uses:

  • on muscles and joints
  • temporarily relieves minor aches and pains

Warnings:

For external use only

  • avoid contact with eyes.

DO NOT USE

  • by mouth
  • with tight bandages
  • in nostrils
  • on wounds or damaged skin
  • in or near eyes
  • Do not apply to infected or open wounds.
    ​

When using this product:


DO NOT

  • heat
  • microwave
  • add to hot water or any container containing hot water. This may cause splattering and result in burns.

Stop Use and Ask Doctor if:

  • muscle aches and pains persist more than 7 days or come back
  • if irritation occurs, discontinue use

If pregnant or breast-feeding:

ask a health professional before use.

Directions:

Directions:

Adults and chldren 2 years and over:

  • rub on sore aching muscles
  • not more than three times per 24 hours or as directed by doctor

INACTIVE INGREDIENTS:

Shea Butter, Blue Breeze Organic Coconut Oil,

X-Factor Gold High Vitamin Butter Oil, White Bees Wax,

Blue Ice Fermented Cod Liver Oil, Cranberry Seed Oil,

Peppermint Oil, Rosemary Oil.

Contains: Cod, milk, shea nut, and coconut.

NDC 18472-175-01

BLUE ICE™

FERMENTED COD LIVER OIL

CALM BALM

A Deep Muscle and Joint Rub

With:

Blue Ice™ Fermented Cod Liver Oil - High Vitamin Butter Oil

Blue Breeze™ Organic Virgin Coconut Oil - Wild Crafted Shea Butter

MM1
BLUE ICE FERMENTED COD LIVER OIL CALM BALM 
camphor, menthol, eucalyptus oil rub salve
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:18472-175
Route of AdministrationTopical
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CAMPHOR (NATURAL) (UNII: N20HL7Q941) (CAMPHOR (NATURAL) - UNII:N20HL7Q941) CAMPHOR (NATURAL)1.30 g  in 49.5 g
EUCALYPTUS OIL (UNII: 2R04ONI662) (EUCALYPTUS OIL - UNII:2R04ONI662) EUCALYPTUS OIL1.73 g  in 49.5 g
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL0.37 g  in 49.5 g
Inactive Ingredients
Ingredient NameStrength
SHEA BUTTER (UNII: K49155WL9Y) 15.59 g  in 49.5 g
COCONUT OIL (UNII: Q9L0O73W7L) 12.87 g  in 49.5 g
OLEIC ACID (UNII: 2UMI9U37CP) 7.43 g  in 49.5 g
WHITE WAX (UNII: 7G1J5DA97F) 5.45 g  in 49.5 g
COD LIVER OIL (UNII: BBL281NWFG) 3.86 g  in 49.5 g
CRANBERRY SEED OIL (UNII: 73KDS3BW5E) 10.59 g  in 49.5 g
PEPPERMINT OIL (UNII: AV092KU4JH) 0.13 g  in 49.5 g
ROSEMARY OIL (UNII: 8LGU7VM393) 0.01 g  in 49.5 g
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:18472-175-0149.5 g in 1 JAR09/13/2011
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34809/01/2011
Labeler - ABS Corporation (048022727)
Registrant - ABS Corporation (048022727)
Establishment
NameAddressID/FEIBusiness Operations
ABS Corporation048022727api manufacture(18472-175) , pack(18472-175) , label(18472-175)

Revised: 2/2014
Document Id: 65ee60ad-1906-4d96-9fe8-0203e0890d46
Set id: f1aa8144-b0bc-48df-9735-4b880f4acd86
Version: 7
Effective Time: 20140204
 
ABS Corporation