Super White Stuff Pain Relief

Super White Stuff Pain Relief
SPL v3
SPL
SPL Set ID b4278b70-e9a6-4d1f-bbad-257fe437b86a
Route
TOPICAL
Published
Effective Date 2021-04-01
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Menthol (14 mg)
Inactive Ingredients
Carbomer Interpolymer Type A (allyl Sucrose Crosslinked) Aloe Vera Leaf Chamaemelum Nobile Flower Oil Water Arnica Montana Flower Ascorbyl Palmitate Calendula Officinalis Flower Caprylyl Glycol Centaurea Cyanus Flower Chamomile Tanacetum Parthenium Whole Coriander Oil Emu Oil Hamamelis Virginiana Root Bark/stem Bark Lamium Album Whole Dimethyl Sulfone Phenoxyethanol Salix Nigra Bark Sodium Cocoyl Isethionate Sodium Hydroxide Sorbitol Edetate Sodium Tilia Cordata Whole .alpha.-tocopherol Acetate Vitis Vinifera Seed

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2021-04-19

Description

Menthol, USP (1.4%)

Purpose

Topical Analgesic


Medication Information

Purpose

Topical Analgesic

Description

Menthol, USP (1.4%)

Uses:

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

Purpose:

Topical Analgesic

Warnings:

For external use only.

Do Not Use

on wounded, damaged or irritated skin.

Directions:

Apply to affected area not more than 3 or 4 time a day.

Consult A Doctor

before use on children under 12 if arthritis conditions are present. For all other listed uses, consult a doctor before use on children under 2.

Package Labeling:

Active Ingredient:

Menthol, USP (1.4%)

Other Information:

Store at room temperature.

Inactive Ingredients:

Acrylates/C10-30 Alkyl Acrylate Crosspolymer, 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, Caprylyl Glycol, Centraurea Cyanus (Cornflower) Extract, Chamomilla Recutita (Chamomile) Extract, Chrysanthemum Parthenium (Feverfew) Extract, Coriandrum Sativum (Coriander) Oil, Emu Oil, Hamamelis Virginiana (Witch Hazel), Lamium Album (White Nettle) Extract, Methylsulfonylmethane (MSM), Phenoxyethanol, Salix Nigra (Willow) Bark Extract, Sodium Cocoyl Isethionate, Sodium Hydroxide, Sorbitol, Tetrasodium EDTA, Tilia Cordata (Linden) Extract, Tocopheryl Acetate (Vitamin E), Vitis Vinifera (Grape) Seed Extarct.

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 clears up and occurs again within a few days.

If Pregnant Or Breat 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 associsted with arthritis, simple backache, sprains, strains and bruises.

Purpose:

Topical Analgesic

Warnings:

For external use only.

Do Not Use (Do not use)

on wounded, damaged or irritated skin.

Directions:

Apply to affected area not more than 3 or 4 time a day.

Consult A Doctor (Consult a doctor)

before use on children under 12 if arthritis conditions are present. For all other listed uses, consult a doctor before use on children under 2.

Package Labeling:

Active Ingredient:

Menthol, USP (1.4%)

Other Information:

Store at room temperature.

Inactive Ingredients:

Acrylates/C10-30 Alkyl Acrylate Crosspolymer, 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, Caprylyl Glycol, Centraurea Cyanus (Cornflower) Extract, Chamomilla Recutita (Chamomile) Extract, Chrysanthemum Parthenium (Feverfew) Extract, Coriandrum Sativum (Coriander) Oil, Emu Oil, Hamamelis Virginiana (Witch Hazel), Lamium Album (White Nettle) Extract, Methylsulfonylmethane (MSM), Phenoxyethanol, Salix Nigra (Willow) Bark Extract, Sodium Cocoyl Isethionate, Sodium Hydroxide, Sorbitol, Tetrasodium EDTA, Tilia Cordata (Linden) Extract, Tocopheryl Acetate (Vitamin E), Vitis Vinifera (Grape) Seed Extarct.

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 If (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 clears up and occurs again within a few days.

If Pregnant Or Breat Feeding  (If pregnant or breat-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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