Label: BLUE ICE FERMENTED COD LIVER OIL CALM BALM- camphor, menthol, eucalyptus oil rub salve
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Contains inactivated NDC Code(s)
NDC Code(s): 18472-175-01 - Packager: ABS Corporation
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph not final
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 Label Information
Updated February 4, 2014
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- Official Label (Printer Friendly)
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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
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
BLUE ICE FERMENTED COD LIVER OIL CALM BALM
camphor, menthol, eucalyptus oil rub salveProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:18472-175 Route of Administration Topical Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength 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 OIL 1.73 g in 49.5 g MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL 0.37 g in 49.5 g Inactive Ingredients Ingredient Name Strength 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 Code Package Description Marketing Start Date Marketing End Date 1 NDC:18472-175-01 49.5 g in 1 JAR 09/13/2011 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part348 09/01/2011 Labeler - ABS Corporation (048022727) Registrant - ABS Corporation (048022727) Establishment Name Address ID/FEI Business Operations ABS Corporation 048022727 api manufacture(18472-175) , pack(18472-175) , label(18472-175)
