Emu Therapy Cool Menthol Therapy Pain Relief Cream

Emu Therapy Cool Menthol Therapy Pain Relief Cream
SPL v4
SPL
SPL Set ID 16894346-3513-41b1-b09f-72d84edcc4ac
Route
TOPICAL
Published
Effective Date 2023-07-22
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Menthol (27.5 mg)
Inactive Ingredients
Aloe Vera Leaf Water Arnica Montana Flower Ascorbyl Palmitate Calendula Officinalis Flower Capsaicin Carbomer Homopolymer, Unspecified Type Chamomile Coriander Emu Oil Ethylhexylglycerin Fd&c Blue No. 1 Fd&c Yellow No. 5 Glycerin Hamamelis Virginiana Root Bark/stem Bark Hypericum Perforatum Whole Lamium Album Whole Dimethyl Sulfone Phenoxyethanol Salix Alba Bark Sodium Lauryl Sulfate Sorbitol Feverfew Trolamine

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2023-08-08

Description

Menthol, USP (2.75%)

Purpose

Topical Analgesic


Medication Information

Purpose

Topical Analgesic

Description

Menthol, USP (2.75%)

Uses:

Temporary relief of minor aches and pains associated with arthritis, simple backache, strains, sprains, and bruises.

Purpose:

Topical Analgesic

Warnings:
  • For external use only.
Do Not Use

on wounded, damaged or irritated skin.

Directions:
  • For adults and children 2 years of age and older: apply to affected area not more than 3 or 4 times a day. Consult a doctor before using for children under 2 years of age.
Package Labeling:

Active Ingredient:

Menthol, USP (2.75%)

Inactive Ingredients:

Aloe Barbadensis leaf (Aloe Vera Gel) Juice, Anthemis Nobilis (Roman Chamomile) Oil, Aqua (Deionized water), Arnica Montana Flower Extract, Ascorbyl Palmitate (Vitamin C), Calendula Officinalis Extract, Capsaicin, Carbomer, Centaurea Cyanus (Cornflower) Extract, Chamomilla Matricaria (Chamomile) Extract, Coriandrum Sativum (Coriander) Oil, Emu Oil, Ethylhexylglycerin, FD&C Blue #1; FD&C Yellow #5, Glycerin, Hamamelis Virginiana (Witch Hazel), Helianthus Annuus (Sunflower) Oil, Hypericum Perforatum (St. John's Wort), Lamium Album (White Nettle) Extract, Methylsulfonylmethane (MSM), Parfum (Fragrance), Phenoxyethanol, Salix Alba (Willow) Bark Extract, SD-Alohol 40B, Sodium Lauryl Sulfate, Sorbitol, Tanacetum Parthenium (Feverfew) Extract, Tilla Cordata (Linden) Bark Extract, Triethanolamine.

Questions Or Comments?

1-800-222-0554 or www.coolmentholTheropyPainCream.com

When Using This Product

avoid contact with eyes or mucous membranes, do not bandage tightly.

Stop Use and Ask A Doctor 
  • if you experience a rash and/or a reaction, condition worsens, or if symptoms persist for more than 10 days or clear up and occur again within a few days. 
If Pregnant Or Breast Feeding
  • ask a health professional before use.
Keep Out of Reach of Children.

If swallowed, get medical help or contact a Poison Control Center right away.


Structured Label Content

Uses:

Temporary relief of minor aches and pains associated with arthritis, simple backache, strains, sprains, and bruises.

Purpose:

Topical Analgesic

Warnings:
  • For external use only.
Do Not Use (Do not use)

on wounded, damaged or irritated skin.

Directions:
  • For adults and children 2 years of age and older: apply to affected area not more than 3 or 4 times a day. Consult a doctor before using for children under 2 years of age.
Package Labeling:

Active Ingredient:

Menthol, USP (2.75%)

Inactive Ingredients:

Aloe Barbadensis leaf (Aloe Vera Gel) Juice, Anthemis Nobilis (Roman Chamomile) Oil, Aqua (Deionized water), Arnica Montana Flower Extract, Ascorbyl Palmitate (Vitamin C), Calendula Officinalis Extract, Capsaicin, Carbomer, Centaurea Cyanus (Cornflower) Extract, Chamomilla Matricaria (Chamomile) Extract, Coriandrum Sativum (Coriander) Oil, Emu Oil, Ethylhexylglycerin, FD&C Blue #1; FD&C Yellow #5, Glycerin, Hamamelis Virginiana (Witch Hazel), Helianthus Annuus (Sunflower) Oil, Hypericum Perforatum (St. John's Wort), Lamium Album (White Nettle) Extract, Methylsulfonylmethane (MSM), Parfum (Fragrance), Phenoxyethanol, Salix Alba (Willow) Bark Extract, SD-Alohol 40B, Sodium Lauryl Sulfate, Sorbitol, Tanacetum Parthenium (Feverfew) Extract, Tilla Cordata (Linden) Bark Extract, Triethanolamine.

Questions Or Comments? (Questions or Comments?)

1-800-222-0554 or www.coolmentholTheropyPainCream.com

When Using This Product (When using this product)

avoid contact with eyes or mucous membranes, do not bandage tightly.

Stop Use and Ask A Doctor  (Stop use and ask a doctor )
  • if you experience a rash and/or a reaction, condition worsens, or if symptoms persist for more than 10 days or clear up and occur again within a few days. 
If Pregnant Or Breast Feeding (If pregnant or Breast-Feeding)
  • ask a health professional before use.
Keep Out of Reach of Children. (Keep out of reach of children.)

If swallowed, get medical help or contact a Poison Control Center right away.


Advanced Ingredient Data


Raw Label Data

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