THERAFREEZE- menthol gel

THERAFREEZE by

Drug Labeling and Warnings

THERAFREEZE by is a Otc medication manufactured, distributed, or labeled by Astrum Pharma. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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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:

• Avoid contact with eyes or mucous membrane.
• Do not apply to wounds or damaged skin.
• Do not use with other ointments, creams, sprays or liniments.
• Do not apply to irritated skin or if excessive irritation develops.
• Do not bandage tightely.
• Wash hands after use with cold water.
• Do not use with a heating pad or device.

Stop Use and Ask Doctor if

• conditions worsen.
• symptoms persist for more than 7 days.
• symptoms clear up and occur again within a few days.
  

If pregnant or breastfeeding:

Ask a health professional before use.

KEEP OUT OF REACH OF CHILDREN

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

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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

INGREDIENTS AND APPEARANCE

THERAFREEZE 
menthol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 57329-010
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL	60 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 57329-010-01	473 mL in 1 TUBE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part341	08/08/2013

Labeler - Astrum Pharma (026303692)