Therafreeze
FDA Label NDC 57329-010

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Astrum Pharma for the product Therafreeze (NDC 57329-010). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding other, active ingredients, purpose, uses, warnings, when using this product:, stop use and ask doctor if, if pregnant or breastfeeding:, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Other

Drug Facts

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

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.

Otc - 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.

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 (Label 1)

Therafreeze Display (Label 1)

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