Procure Green Pain Gel

Procure Green Pain Gel
SPL v4
SPL
SPL Set ID e69c0b68-d408-9fd2-e053-2a95a90ac934
Route
TOPICAL
Published
Effective Date 2016-09-19
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Menthol (5 g)
Inactive Ingredients
Fd&c Blue No. 1 Silicon Dioxide Fd&c Yellow No. 5 Aloe Vera Leaf Arctium Lappa Root Arnica Montana Flower Calendula Officinalis Flower Green Tea Leaf Carboxypolymethylene Glycerin Isopropyl Alcohol Isopropyl Myristate .alpha.-tocopherol Trolamine Water

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2016-09-19

Description

Menthol 5%

Purpose

Pain Relieving


Medication Information

Purpose

Pain Relieving

Description

Menthol 5%

Uses

Temporarily relieves minor aches and pains of muscles and joints associated with: ■Simple backache

Arthritis ■Strains ■Bruises ■Sprains

Section 60561-8

■Store at 20˚-25˚C (68˚-77˚F)



■Store in a cool dry place away from direct sunlight

Warnings

For external use only

Directions

■Adults and children 2 years of age and older: rub a thin film over affected area not more than 3 to 4 times daily ■Children under 2 years

of age: consult a physician ■Wash hands after use with cool water

Flammable:

Keep away from excessive heat or open flame.

Package Labeling:

Active Ingredients

Menthol 5%

Inactive Ingredients

: Aloevera Extract, Arctium Lappa Root (Burdock) Extract, Arnica Montana Flower Extract, Calendula Officinalis Extract, Carbopol, FD&C Blue No. 1, FD&C Yellow No. 5, Glycerine, Green Tea Extract, Isopropyl Alcohol, Isopropyl Myristate, Silica, Triethanolamine, Vitamin E, Water

When Using This Product:

■Use only as directed

■Avoid contact with the eyes or on mucous membranes

■Do not apply to wounds or damaged skin

■Do not apply to irritated skin or if excessive irritation develops ■Do not bandage tightly or use with heating pad or device

Stop Use and Ask A Doctor If:

■You experience pain, swelling or blistering of the skin

■Condition worsens or if symptoms persist for more than 7 days or clear up and occur again within a few days

■Arthritis pain persists for more than 10 days or redness is present, or in conditions affecting children under 12 years of age

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

Temporarily relieves minor aches and pains of muscles and joints associated with: ■Simple backache

Arthritis ■Strains ■Bruises ■Sprains

Section 60561-8 (60561-8)

■Store at 20˚-25˚C (68˚-77˚F)



■Store in a cool dry place away from direct sunlight

Purpose

Pain Relieving

Warnings

For external use only

Directions

■Adults and children 2 years of age and older: rub a thin film over affected area not more than 3 to 4 times daily ■Children under 2 years

of age: consult a physician ■Wash hands after use with cool water

Flammable:

Keep away from excessive heat or open flame.

Package Labeling:

Active Ingredients

Menthol 5%

Inactive Ingredients

: Aloevera Extract, Arctium Lappa Root (Burdock) Extract, Arnica Montana Flower Extract, Calendula Officinalis Extract, Carbopol, FD&C Blue No. 1, FD&C Yellow No. 5, Glycerine, Green Tea Extract, Isopropyl Alcohol, Isopropyl Myristate, Silica, Triethanolamine, Vitamin E, Water

When Using This Product: (When using this product:)

■Use only as directed

■Avoid contact with the eyes or on mucous membranes

■Do not apply to wounds or damaged skin

■Do not apply to irritated skin or if excessive irritation develops ■Do not bandage tightly or use with heating pad or device

Stop Use and Ask A Doctor If: (Stop use and ask a doctor if:)

■You experience pain, swelling or blistering of the skin

■Condition worsens or if symptoms persist for more than 7 days or clear up and occur again within a few days

■Arthritis pain persists for more than 10 days or redness is present, or in conditions affecting children under 12 years of age

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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