ICY COLD COOL PAIN RELIEVING- menthol, camphor gel 
COMPASS HEALTH BRANDS CORP.

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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ACTIVE INGREDIENTS

MENTHOL 3.9%

CAMPHOR 0.4%

PURPOSE

TOPICAL ANALGESIC

COUNTER IRRITANT

USES

temporary relief of

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

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.

Thera Med Icy Cold Cool Pain Relieving Gel ( 16oz.)

ICY COLD COOL PAIN RELIEVING 
menthol, camphor gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71323-101
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL3.9 g  in 100 mL
CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET) (CAMPHOR (SYNTHETIC) - UNII:5TJD82A1ET) CAMPHOR (SYNTHETIC)0.4 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
ISOPROPYL ALCOHOL (UNII: ND2M416302)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
GLYCERIN (UNII: PDC6A3C0OX)  
CARBOMER 940 (UNII: 4Q93RCW27E)  
ILEX PARAGUARIENSIS LEAF (UNII: 1Q953B4O4F)  
SILICON (UNII: Z4152N8IUI)  
AMINOMETHYLPROPANOL (UNII: LU49E6626Q)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
UNCARIA TOMENTOSA WHOLE (UNII: U6P1SV66LA)  
BOSWELLIA SERRATA WHOLE (UNII: X7B7P649WQ)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:71323-101-26473 mL in 1 BOTTLE; Type 0: Not a Combination Product03/22/2017
2NDC:71323-101-913785 mL in 1 JUG; Type 0: Not a Combination Product03/22/2017
3NDC:71323-101-1388.8 mL in 1 BOTTLE; Type 0: Not a Combination Product03/22/2017
4NDC:71323-101-14118 mL in 1 BOTTLE; Type 0: Not a Combination Product03/22/2017
5NDC:71323-101-055 mL in 1 POUCH; Type 0: Not a Combination Product03/22/2017
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/FEIBusiness Operations
DIVERSIFIED MANUFACTURING CORP185073996manufacture(71323-101)

Revised: 3/2017
Document Id: 7a9eefa7-6163-46ef-88c3-871c1ba7d2ac
Set id: 4362fc73-a534-472b-bb09-e0237a1e4ab3
Version: 1
Effective Time: 20170322
 
COMPASS HEALTH BRANDS CORP.