Label: THERAFREEZE- menthol gel
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Contains inactivated NDC Code(s)
NDC Code(s): 57329-010-01 - Packager: Astrum Pharma
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph 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 August 8, 2013
If you are a consumer or patient please visit this version.
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- Official Label (Printer Friendly)
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- Active Ingredients
- Purpose
- Uses
- Warnings
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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
- If pregnant or breastfeeding:
- KEEP OUT OF REACH OF CHILDREN
- Directions
- Other information
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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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INGREDIENTS AND APPEARANCE
THERAFREEZE
menthol gelProduct 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)