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ICY COLD COOL PAIN RELIEVING

Medically reviewed on March 22, 2017

Dosage form: gel
Ingredients: MENTHOL 3.9g in 100mL, CAMPHOR (SYNTHETIC) 0.4g in 100mL
Labeler: COMPASS HEALTH BRANDS CORP.
NDC Code: 71323-101

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.

ACTIVE INGREDIENTS

MENTHOL 3.9%

CAMPHOR 0.4%

PURPOSE

TOPICAL ANALGESIC

COUNTER IRRITANT

USES

temporary relief of

  • Arthritis
  • Backache
  • Strains/Sprains

WARNINGS

FOR EXTERNAL USE ONLY

Do not use near eyes, mouth, mucus membranes, genitals, cuts, rashes and sores. If contact occurs, flush with cold water. Do not use with heating pad or device, or under bandages. Do not use if pregnant or breastfeeding. Please consult your physician prior to use. Do not apply to wounds or damaged skin.

Stop use and ask a doctor if irritation persists.

Keep out of reach of children. If accidentally ingested, seek medical help or contact a Poison Control Center immediately.

DIRECTIONS
  • Adults and children 2 years of age and older: apply to affected area not more than 3 to 4 times daily.
  • Rub in thoroughly until gel is absorbed.

INACTIVE INGREDIENTS

Water, Isopropyl Alcohol, Propylene Glycol, Glycerin, Carbomer, Ilex Paraguariensis Leaf Extract, Hydrated Silica, Aminomethyl Propanol, Methyl Paraben, Uncaria Tomentosa Extract, Boswelia Serrata Extract, Camphor for scent.

ICY COLD COOL PAIN RELIEVING 
menthol, camphor gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71323-101
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MENTHOL (MENTHOL) MENTHOL3.9 g  in 100 mL
CAMPHOR (SYNTHETIC) (CAMPHOR (SYNTHETIC)) CAMPHOR (SYNTHETIC)0.4 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
WATER 
ISOPROPYL ALCOHOL 
PROPYLENE GLYCOL 
GLYCERIN 
CARBOMER 940 
ILEX PARAGUARIENSIS LEAF 
SILICON 
AMINOMETHYLPROPANOL 
METHYLPARABEN 
UNCARIA TOMENTOSA WHOLE 
BOSWELLIA SERRATA WHOLE 
Packaging
#Item CodePackage Description
1NDC:71323-101-26473 mL in 1 BOTTLE
2NDC:71323-101-913785 mL in 1 JUG
3NDC:71323-101-1388.8 mL in 1 BOTTLE
4NDC:71323-101-14118 mL in 1 BOTTLE
5NDC:71323-101-055 mL in 1 POUCH
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34803/22/2017
Labeler - COMPASS HEALTH BRANDS CORP. (827221698)
Establishment
NameAddressID/FEIOperations
DIVERSIFIED MANUFACTURING CORP185073996manufacture(71323-101)

 
COMPASS HEALTH BRANDS CORP.

Further information

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

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