Drug Facts

Drug Facts
SPL v2
SPL
SPL Set ID 79c92980-a787-415f-81db-60ff43da82a7
Route
TOPICAL
Published
Effective Date 2013-12-20
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 Polyoxyl 20 Cetostearyl Ether Steareth-2

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2007-05-01

Description

Menthol 5%

Purpose

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


Medication Information

Purpose

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

Description
This product is manufactured exclusively for: RZN Nutraceuticals, Inc. Miami, FL 33186





• Soothing and medicated analgesic

rub for aching joints and muscles



• Effective for pre-exercise warm-up



• Deep penetrating therapeutic pain relief



• With skin moisturizing conditioners

aloe, shea butter, avocado, and

grape seed oil



• Contains Arthri-Zen Relief’s

clinically tested herbal formula




Uses

For the 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 condition 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%

Inactive Ingredients

Water, Methyl Glucose Sesquistearate, Arthri-Zen Relief 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, Ceteareth-20, Steareth-2.



Questions Or Comments?

1-800-226-7031 or [email protected]

Principal Display Panel

Fast and Long Lasting

Pain Relief

Arthri Zen

RELIEF CREAM



Temporary Relief of Minor Aches and Pains Associated with

Arthritis, Backaches, Sprains, Bruises, Strains, and Stiffness.

Net wt 3.0 oz.(85g)


Structured Label Content

Uses

For the temporary relief of minor aches and pains associated with arthritis, backaches, sprains, bruises, strains, and stiffness.

Description (34089-3)
This product is manufactured exclusively for: RZN Nutraceuticals, Inc. Miami, FL 33186





• Soothing and medicated analgesic

rub for aching joints and muscles



• Effective for pre-exercise warm-up



• Deep penetrating therapeutic pain relief



• With skin moisturizing conditioners

aloe, shea butter, avocado, and

grape seed oil



• Contains Arthri-Zen Relief’s

clinically tested herbal formula




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 condition 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%

Inactive Ingredients

Water, Methyl Glucose Sesquistearate, Arthri-Zen Relief 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, Ceteareth-20, Steareth-2.



Questions Or Comments? (Questions or comments?)

1-800-226-7031 or [email protected]

Principal Display Panel

Fast and Long Lasting

Pain Relief

Arthri Zen

RELIEF CREAM



Temporary Relief of Minor Aches and Pains Associated with

Arthritis, Backaches, Sprains, Bruises, Strains, and Stiffness.

Net wt 3.0 oz.(85g)


Advanced Ingredient Data


Raw Label Data

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