5697ae1d-ead6-46a0-8074-d83bdc0f4605

SPL v1
SPL
SPL Set ID 5697ae1d-ead6-46a0-8074-d83bdc0f4605
Route
topical
Published
Effective Date 2019-02-27
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
menthol (5.0 g)
Inactive Ingredients
water aloe vera leaf witch hazel watercress rosemary isopropyl alcohol glycerin coconut oil almond oil emu oil carbomer homopolymer type c (allyl pentaerythritol crosslinked) sodium hydroxide silicon dioxide fd&c yellow no. 5 fd&c blue no. 1 dmdm hydantoin

Identifiers & Packaging

Marketing Status
otc monograph not final active Since 2019-02-16

Purpose

Cooling Pain Relief

Description

Menthol ---5.0%


Medication Information

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 develpes. 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 percist for more than 7 days or clear up and recur.

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

Uses

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

Purpose

Cooling Pain Relief

Directions

ADULT AND CHILDREN 2 YEARS OF AGE AND OLDER: RUB A THIN FILM OVER AFFECTED AREAS NOT MORE THAN 4 TIMES DAILY. MASSAGE NOT NECESSARY.

CHILDREN UNDER 2 YEARS OF AGE: CONSULT PHYSICIAN.

Inactive Ingredients

PURIFIED WATER, Extract of Aloe Vera, Witch Hazel, Water Cress and Rosemary, Isopropanol, Glycerin, Coconut Oil, Sweet Almond Oil, Emu Oil, Carbomer, Sodium Hydroxide, Silica, F. D. & C Yellow #5, F. D.& C Blue #1, DMDM Hydantoin

Description

Menthol ---5.0%

Section 50565-1

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

Section 51945-4

Active Ingredient

Menthol ---5.0%


Structured Label Content

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 develpes. 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 percist for more than 7 days or clear up and recur.

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

Uses (USES)

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

Purpose (PURPOSE)

Cooling Pain Relief

Directions (DIRECTIONS)

ADULT AND CHILDREN 2 YEARS OF AGE AND OLDER: RUB A THIN FILM OVER AFFECTED AREAS NOT MORE THAN 4 TIMES DAILY. MASSAGE NOT NECESSARY.

CHILDREN UNDER 2 YEARS OF AGE: CONSULT PHYSICIAN.

Inactive Ingredients (INACTIVE INGREDIENTS)

PURIFIED WATER, Extract of Aloe Vera, Witch Hazel, Water Cress and Rosemary, Isopropanol, Glycerin, Coconut Oil, Sweet Almond Oil, Emu Oil, Carbomer, Sodium Hydroxide, Silica, F. D. & C Yellow #5, F. D.& C Blue #1, DMDM Hydantoin

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)

Active Ingredient (ACTIVE INGREDIENT)

Menthol ---5.0%


Advanced Ingredient Data


Raw Label Data

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