Therafrezzetm

Therafrezzetm
SPL v1
SPL
SPL Set ID 7660635b-db41-4bfa-95f2-ecb1837e4931
Route
TOPICAL
Published
Effective Date 2013-08-08
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Menthol (60 mg)
Inactive Ingredients
Aloe Vera Leaf Water Arctium Lappa Root Arnica Montana Flower Indian Frankincense C13-14 Isoparaffin Calendula Officinalis Flower Green Tea Leaf Carbomer Homopolymer Type C (allyl Pentaerythritol Crosslinked) Cetearyl Olivate Citrus Limon Fruit Oil Ethylhexylglycerin Glyceryl Monostearate Witch Hazel Sunflower Oil Ilex Paraguariensis Leaf Laureth-7 Dimethyl Sulfone Peg-100 Stearate Phenoxyethanol Polyacrylamide (10000 Mw) Polysorbate 20 Propylene Glycol Sorbitan Olivate Stearic Acid .alpha.-tocopherol Acetate Trolamine

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH FINAL Active Since 2013-08-08

Description

Drug Facts

Purpose

Pain Reliever


Medication Information

Purpose

Pain Reliever

Description

Drug Facts

Uses

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

Section 42229-5

Drug Facts

Section 50565-1

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

Warnings

For external use only.

Flammable: Keep away from excessive heat or open flame.

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

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.

Active Ingredients

Menthol USP 6%

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

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.


Structured Label Content

Uses

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

Section 42229-5 (42229-5)

Drug Facts

Section 50565-1 (50565-1)

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

Purpose

Pain Reliever

Warnings

For external use only.

Flammable: Keep away from excessive heat or open flame.

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

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 (Other information)

Store in cool dry place.

Active Ingredients

Menthol USP 6%

Inactive Ingredients: (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

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 (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: (If pregnant or breastfeeding:)

Ask a health professional before use.


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Raw Label Data

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