SPL v1
SPL
SPL Set ID b6f8e297-75a0-4984-b2aa-5ab7d947654b
Route
TOPICAL
Published
Effective Date 2019-02-27
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Menthol (10.5 g)
Inactive Ingredients
Water Aloe Vera Leaf Witch Hazel Watercress Rosemary Isopropyl Alcohol Glycerin Polysorbate 20 Coconut Oil Almond Oil Emu Oil

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2019-02-16

Description

Menthol ---10.5%

Purpose

Cooling Pain Relief


Medication Information

Purpose

Cooling Pain Relief

Description

Menthol ---10.5%

Uses

Temporary relief from minor aches and pains of sore muscles and joints associated with arthrilis backaches strains and sprains

Section 50565-1

Keep out of reach of children: if accidently ingested get medical help or contact Poison Control Center immediately

Section 51945-4

Warnings

For external use only.

Flammable; Keep away from excessive heat or open-flame.

Ask doctor before use if you have: Sensitive skin.

When using this product: Avoid contact with the eyes or mucus membranes. Do not apply to wounds or damaged skin. Do not use with other ointments, creams, sprays or liniments. Do not apply to irritated skin of if excessive irritation develops. Do not bandage. Wash hand after use with cold water. Do not use heating pads or device. Store in a cool dry place. Stop use and ask doctor if: condition worsens or if symptoms persist for more than 7 days or clear up and recur.

If pregnant or breast feeding: ask a health professional before use.

Directions

Adult and children 12 years of age and older: Spray on to the affected areas not more than four times daily. Massage not necessary.

Children under 12 years of age: Consult physician.

Active Ingredient

Menthol ---10.5%

Inactive Ingredients

Purified water, Extract of Aloe Vera, Witch Hazel, Water Cress and Rosemary, Isopropanol, Glycerin, Polysorbate 20, Coconut Oil, Sweet Almond Oil, Emu Oil


Structured Label Content

Uses (USES)

Temporary relief from minor aches and pains of sore muscles and joints associated with arthrilis backaches strains and sprains

Section 50565-1 (50565-1)

Keep out of reach of children: if accidently ingested get medical help or contact Poison Control Center immediately

Section 51945-4 (51945-4)

Purpose

Cooling Pain Relief

Warnings (WARNINGS)

For external use only.

Flammable; Keep away from excessive heat or open-flame.

Ask doctor before use if you have: Sensitive skin.

When using this product: Avoid contact with the eyes or mucus membranes. Do not apply to wounds or damaged skin. Do not use with other ointments, creams, sprays or liniments. Do not apply to irritated skin of if excessive irritation develops. Do not bandage. Wash hand after use with cold water. Do not use heating pads or device. Store in a cool dry place. Stop use and ask doctor if: condition worsens or if symptoms persist for more than 7 days or clear up and recur.

If pregnant or breast feeding: ask a health professional before use.

Directions (DIRECTIONS)

Adult and children 12 years of age and older: Spray on to the affected areas not more than four times daily. Massage not necessary.

Children under 12 years of age: Consult physician.

Active Ingredient

Menthol ---10.5%

Inactive Ingredients (Inactive ingredients)

Purified water, Extract of Aloe Vera, Witch Hazel, Water Cress and Rosemary, Isopropanol, Glycerin, Polysorbate 20, Coconut Oil, Sweet Almond Oil, Emu Oil


Advanced Ingredient Data


Raw Label Data

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