Drug Facts

Drug Facts
SPL v2
SPL
SPL Set ID 7061acd0-ba56-4753-8fa6-eaef302fd224
Route
TOPICAL
Published
Effective Date 2013-12-18
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Menthol (5 g)
Inactive Ingredients
Water Gaultheria Procumbens Top Avocado Oil Stearic Acid Aloe Vera Leaf Grape Seed Oil Cyclomethicone Shea Butter Steareth-10 Phenoxyethanol Methylparaben Polyoxyl 20 Cetostearyl Ether Steareth-2

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2007-12-01

Description

Menthol 5%

Purpose

Menthol 5%.......................................Topical Analgesic


Medication Information

Purpose

Menthol 5%.......................................Topical Analgesic

Description

Menthol 5%

Uses

For temporary relief of minor aches and pains

associated with arthritis, backaches, sprains, bruises,

strains, and stiffness.

Section 50565-1

 KEEP OUT OF REACH OF CHILDREN

Section 50569-3

Consult a physician before use for children under 12 or if; pregnant or nursing;

condition persists more than seven days or clears

up and returns within seven days; excessive skin

irritation occurs; you are prone to allergic

reactions to salicylates, including aspirin.

Section 50570-1

Do not apply to open wounds or damaged skin.

Section 60561-8

– if swallowed get medical help or contact a poison

center right away. • Do not bandage tightly or use

with heating pads.

Warnings
  • For external use only.

  • Use only as directed.

  • Avoid contact with eyes and mucous membranes.

Directions

• Adults and children under 12 years of age and older: apply to affected area

no more than 3 to 4 times daily.

• Children under 12: consult a physician.

• Apply generously and massage into affected areas

until completely absorbed.

• Apply before and after sports or exercise to help soothe aching muscles, muscle strain, and stiffness.

Repeat as needed up to four times a day.

Other Information

Store at 20º to 25º C (68º to 77º F)

Active Ingredients



Menthol 5%

Questions/comments?

714-639-0343 Manufactured for: Pure Science Int.,

Mission Viejo, CA 92692

Inactive Ingredients

Water, Methyl Glucose Sesquistearate, Arthri-Support

Cream Proprietary Herbal Extract Blend,

Natural Oil of Wintergreen (Gaultheria procumbens), Avocado Oil (Persea

gratissima), Stearic Acid, Aloe (Aloe barbadensis), Grape Seed Oil (Vitis

vinifera), Cyclomethicone, Shea Butter (Butyrospermum parkii). Steareth-10,

Phenoxyethanol Methylparaben, Ceteareth-20, Steareth-2.



Principal Display Panel


PURE

SCIENCE

INTERNATIONAL

ARTHRI

SUPPORT

FAST AND LASTING

PAIN REFLIEF!

Supports Joint and

Muscle Comfort

MEDICATED CREAM

net weight 3.0 oz. (85g)




Structured Label Content

Uses

For temporary relief of minor aches and pains

associated with arthritis, backaches, sprains, bruises,

strains, and stiffness.

Section 50565-1 (50565-1)

 KEEP OUT OF REACH OF CHILDREN

Section 50569-3 (50569-3)

Consult a physician before use for children under 12 or if; pregnant or nursing;

condition persists more than seven days or clears

up and returns within seven days; excessive skin

irritation occurs; you are prone to allergic

reactions to salicylates, including aspirin.

Section 50570-1 (50570-1)

Do not apply to open wounds or damaged skin.

Section 60561-8 (60561-8)

– if swallowed get medical help or contact a poison

center right away. • Do not bandage tightly or use

with heating pads.

Purpose

Menthol 5%.......................................Topical Analgesic

Warnings
  • For external use only.

  • Use only as directed.

  • Avoid contact with eyes and mucous membranes.

Directions

• Adults and children under 12 years of age and older: apply to affected area

no more than 3 to 4 times daily.

• Children under 12: consult a physician.

• Apply generously and massage into affected areas

until completely absorbed.

• Apply before and after sports or exercise to help soothe aching muscles, muscle strain, and stiffness.

Repeat as needed up to four times a day.

Other Information

Store at 20º to 25º C (68º to 77º F)

Active Ingredients



Menthol 5%

Questions/comments?

714-639-0343 Manufactured for: Pure Science Int.,

Mission Viejo, CA 92692

Inactive Ingredients

Water, Methyl Glucose Sesquistearate, Arthri-Support

Cream Proprietary Herbal Extract Blend,

Natural Oil of Wintergreen (Gaultheria procumbens), Avocado Oil (Persea

gratissima), Stearic Acid, Aloe (Aloe barbadensis), Grape Seed Oil (Vitis

vinifera), Cyclomethicone, Shea Butter (Butyrospermum parkii). Steareth-10,

Phenoxyethanol Methylparaben, Ceteareth-20, Steareth-2.



Principal Display Panel


PURE

SCIENCE

INTERNATIONAL

ARTHRI

SUPPORT

FAST AND LASTING

PAIN REFLIEF!

Supports Joint and

Muscle Comfort

MEDICATED CREAM

net weight 3.0 oz. (85g)




Advanced Ingredient Data


Raw Label Data

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