icy cold pain relief cream soothes sore muscles and joints

icy cold pain relief cream soothes sore muscles and joints
SPL v1
SPL
SPL Set ID 383f30aa-d0a5-41c1-bd1f-bcc5ed50aa94
Route
topical
Published
Effective Date 2019-09-29
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
menthol (6 mg)
Inactive Ingredients
carbomer 940 isopropyl alcohol isopropyl myristate silicon dioxide glycerin ethylhexylglycerin propylene glycol methylisothiazolinone water

Identifiers & Packaging

Marketing Status
otc monograph not final active Since 2019-09-29

Purpose

Topical Analgesic

Description

Menthol     6%


Medication Information

Purpose

Topical Analgesic

Description

Menthol     6%

Principal Display Panel

Uses:

For temporary relief minor muscular discomfort

Warnings:

For external use only.

Avoid contact with eyes, mucous membrane or broken skin

Directions:

For the temporary relief of minor muscular discomfort. See important warnings under "When using this product". Not for use on children 5 years or younger. Apply liberally to painful area and massage until lotion is absorbed into the skin. Repeat 3-4 times daily. Store at 68 to 77F (20 to 25 C)

Active Ingredients

Menthol     6%

Inactive Ingredients:

Water, Isopropyl Alcohol, Glycerin, Aloe Barbadensis Leaf Extract, Calendula Officinalis Extract, Arctium Lappa (Burdock)Root Extract, Illex Paraguariensis Leaf Extract, Arnica Montana Flower Extract, Boswellia Carterii Resin Extract, CamelliaSinensis (Green Tea) Leaf Extract, Melissa Officinalis (Lemon Balm) Leaf Extract, Camphor, Isopropyl Myristate, Carbomer,Triethanolamine, Silica, Tocopheryl (Vitamin E) Acetate

When Using This Product

do not heat, microwave, and to hot water or any container where heating water may cause splattering and result in burns, use in eyes or directly on mucus membrans, take by mouth or place in nostrill, apply to wounds or damaged skin. Do not use otherwise than as directed

Keep Out of Reach of Children.

if accidentally ingested, getmedical help or contact a Poison Control Center immediately.

Consult A Doctor and Discontinus Use.

if conditions persist for more than 1 week or reocur.


Structured Label Content

Purpose

Topical Analgesic

Principal Display Panel

Uses:

For temporary relief minor muscular discomfort

Warnings:

For external use only.

Avoid contact with eyes, mucous membrane or broken skin

Directions:

For the temporary relief of minor muscular discomfort. See important warnings under "When using this product". Not for use on children 5 years or younger. Apply liberally to painful area and massage until lotion is absorbed into the skin. Repeat 3-4 times daily. Store at 68 to 77F (20 to 25 C)

Active Ingredients (Active ingredients)

Menthol     6%

Inactive Ingredients: (Inactive ingredients:)

Water, Isopropyl Alcohol, Glycerin, Aloe Barbadensis Leaf Extract, Calendula Officinalis Extract, Arctium Lappa (Burdock)Root Extract, Illex Paraguariensis Leaf Extract, Arnica Montana Flower Extract, Boswellia Carterii Resin Extract, CamelliaSinensis (Green Tea) Leaf Extract, Melissa Officinalis (Lemon Balm) Leaf Extract, Camphor, Isopropyl Myristate, Carbomer,Triethanolamine, Silica, Tocopheryl (Vitamin E) Acetate

When Using This Product (When using this product)

do not heat, microwave, and to hot water or any container where heating water may cause splattering and result in burns, use in eyes or directly on mucus membrans, take by mouth or place in nostrill, apply to wounds or damaged skin. Do not use otherwise than as directed

Keep Out of Reach of Children. (Keep out of reach of children.)

if accidentally ingested, getmedical help or contact a Poison Control Center immediately.

Consult A Doctor and Discontinus Use. (Consult a doctor and discontinus use.)

if conditions persist for more than 1 week or reocur.


Advanced Ingredient Data


Raw Label Data

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