THERAFREEZE - menthol gel 
Astrum Pharma

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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THERAFREZZETM

Drug Facts

Active Ingredients

Menthol USP 6%

Purpose

Pain Reliever

Uses

Temporary relief from minor aches and pains from sore muscles & joints associated with arthritis, backache, strains and sprains.

Warnings

For external use only.

Flammable: Keep away from excessive heat or open flame.

Ask a doctor before use if you have: sesnitive skin.

When Using This Product:

Stop Use and Ask Doctor if

If pregnant or breastfeeding:

Ask a health professional before use.

Keep out of reach of children:If accidently ingested, get medical help or contact a Poison Control Center immediately.

Directions

Adults and children 12 years of age and older: Apply on the affacted areas not more than 4 times a day.

Children under 2 years of age: Consult physician.

Other information

Store in cool dry place.

Inactive ingredients:

Aloe Barbadensis Leaf (Aloe Vera Gel) Juice, Aqua (Deionized Water), Arctum Lappa (Burdock) Root Extract, Arnica Montana Extract, Boswellia Serrata Extract, C13-14 Isoparaffin, Calendula Officinalis Extract, Camellia Sinensis (Green Tea) Extract, Carbomer-940, Cetearyl Oliviate, Citrus Media Limonum (Essential Lemon) Oil, Ethylhexylglycerin, Glyceryl Stearate, Hamamelis Virginiana (Witch Hazel) Distillate, Helianthus Annuus (Sunflower) seed Oil, IIex Paraguariensis Leaf (Yerba Mate') Extract, Laureth-7, Methylsulfonylmethane (MSM), PEG - 100 Stearate, Phenoxyethanol, Polyacrylmide, Polysorbate - 20, Propylene Glycol, Sorbitan Olivate, Stearic Acid, Tocopheryl Acetate (Vitamin - E), Triethanolamine.

Questions or Comments? 1-800-590-3906

For more information,
please visit our website
www.astrumpharma.com

Manufactured in the USA

No Animal Testing

Distributed and Marketed by:
Astrum Pharma, Jersey City,
NJ-07307

Principal Display Panel

SOOTHING PAIN RELIEF FROM ARTHRITIS, BACK PAIN,
SORE MUSCLES AND JOINTS

Cool Therapy Pain Relieving Gel

THERAFREEZETM

Vanishing Scent •Natural Menthol •Paraben Free

NDC # 57329-010-01

16 FL OZ

473 ML

therafreeze Display
THERAFREEZE 
menthol gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:57329-010
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL60 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
WATER (UNII: 059QF0KO0R)  
ARCTIUM LAPPA ROOT (UNII: 597E9BI3Z3)  
ARNICA MONTANA FLOWER (UNII: OZ0E5Y15PZ)  
INDIAN FRANKINCENSE (UNII: 4PW41QCO2M)  
C13-14 ISOPARAFFIN (UNII: E4F12ROE70)  
CALENDULA OFFICINALIS FLOWER (UNII: P0M7O4Y7YD)  
GREEN TEA LEAF (UNII: W2ZU1RY8B0)  
CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 4Q93RCW27E)  
CETEARYL OLIVATE (UNII: 58B69Q84JO)  
CITRUS LIMON FRUIT OIL (UNII: 0HNC1J1YED)  
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
WITCH HAZEL (UNII: 101I4J0U34)  
SUNFLOWER OIL (UNII: 3W1JG795YI)  
ILEX PARAGUARIENSIS LEAF (UNII: 1Q953B4O4F)  
LAURETH-7 (UNII: Z95S6G8201)  
DIMETHYL SULFONE (UNII: 9H4PO4Z4FT)  
PEG-100 STEARATE (UNII: YD01N1999R)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
POLYACRYLAMIDE (10000 MW) (UNII: E2KR9C9V2I)  
POLYSORBATE 20 (UNII: 7T1F30V5YH)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
SORBITAN OLIVATE (UNII: MDL271E3GR)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
TROLAMINE (UNII: 9O3K93S3TK)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:57329-010-01473 mL in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34108/08/2013
Labeler - Astrum Pharma (026303692)

Revised: 8/2013
Document Id: b9cbc519-8615-43a5-939e-0e2763e2d5ee
Set id: 7660635b-db41-4bfa-95f2-ecb1837e4931
Version: 1
Effective Time: 20130808
 
Astrum Pharma