Super Blue Stuff Pain Relief Cream

Super Blue Stuff Pain Relief Cream
SPL v4
SPL
SPL Set ID 066a2106-2e25-4df6-9a8d-4417ba190205
Route
TOPICAL
Published
Effective Date 2021-05-25
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 Coriander Oil Emu Oil Hamamelis Virginiana Top 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 Fd&c Blue No. 1

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2020-11-22

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 associated 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.

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, Coriandrum Sativum (Coriander) Oil, Emu Oil, Hamamelis Virginiana (Witch Hazel), Lamium Album (White Nettle) Extract, Methylsulfonylmethane (MSM), Parfum (Fragrance), Phenoxyethanol, Sali Nigra (Willow) Bark Extract, Sodium Cocoyl Isethionate, Sodium Hydroxide, Sorbitol, Tetrasodium EDTA, Tilia Cordata (Linden)Extract, Tocopheryl Acetate (Vitamin E), Vitis Vinifera (Grape) Seed Extract, FD&C Blue #1

Package Labeling: 5ml

Package Labeling:85ml

Package Labeling:118ml

Package Labeling:355ml

Questions Or Comments?

1-800-452-3700 or www.bluespringwellness.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 clears up and occurs again within a few days.

Keep Out of Reach of Children.

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

If Pregnant Or Breast Feeding 

ask a health professional before use.


Structured Label Content

Uses:

Temporary relief of minor aches and pains associated 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.

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, Coriandrum Sativum (Coriander) Oil, Emu Oil, Hamamelis Virginiana (Witch Hazel), Lamium Album (White Nettle) Extract, Methylsulfonylmethane (MSM), Parfum (Fragrance), Phenoxyethanol, Sali Nigra (Willow) Bark Extract, Sodium Cocoyl Isethionate, Sodium Hydroxide, Sorbitol, Tetrasodium EDTA, Tilia Cordata (Linden)Extract, Tocopheryl Acetate (Vitamin E), Vitis Vinifera (Grape) Seed Extract, FD&C Blue #1

Package Labeling: 5ml

Package Labeling:85ml

Package Labeling:118ml

Package Labeling:355ml

Questions Or Comments? (Questions or Comments?)

1-800-452-3700 or www.bluespringwellness.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 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.

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.

If Pregnant Or Breast Feeding  (If Pregnant or Breast-Feeding )

ask a health professional before use.


Advanced Ingredient Data


Raw Label Data

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