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

Purpose

Pain Reliever

Description

Drug Facts


Medication Information

Warnings

For external use only.

Flammable: Keep away from excessive heat or open flame.

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

Uses

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

Purpose

Pain Reliever

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.

Description

Drug Facts

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

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.

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.

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

Warnings

For external use only.

Flammable: Keep away from excessive heat or open flame.

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

Uses

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

Purpose

Pain Reliever

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.

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

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.

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.

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.


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)