Cool N Heat

Cool N Heat
SPL v6
SPL
SPL Set ID a24cde17-280b-8358-e053-2a95a90af67d
Route
TOPICAL
Published
Effective Date 2018-11-09
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Menthol (160 mg)
Inactive Ingredients
Glycerin Propylene Glycol

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2018-11-09

Description

Menthol 16% Topical analgesic

Purpose

temporarily relief of pain and itching associated with: arthritis • simple backache • muscle strains • bruises • cramps • muscle sprains

Dosage and Administration

Shake well adults and children 12 years of age and older spray on affected area not more than 3 to 4 times daily children under 12 years of age consult a doctor


Medication Information

Purpose

temporarily relief of pain and itching associated with: arthritis • simple backache • muscle strains • bruises • cramps • muscle sprains

Dosage and Administration

Shake well

adults and children 12 years of age and older spray on affected area not more than 3 to 4 times daily

children under 12 years of age consult a doctor

Description

Menthol 16% Topical analgesic

Uses

Temporality alleviates minor aches and pains of muscles and joints associated with Arthritis, Simple Backache, Strains, Bruises, or Sprains

Warnings:

For external use only.

Flammable: Do not use while smoking or near heat or flames. Avoid long term storage

above 104°F. Do not puncture or incinerate. Contents under pressure. Do not store at temperatures above 120°F.

When using this product avoid contact with eyes and mucous membranes. Do not apply to wounds or damaged skin. Do not bandage tightly. Use only as directed.

Stop use and ask doctor if condition worsens or symptoms persist for more than 7 days or clear up and occur again within a few days. Do not use for longer than 1 week.

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center immediately.

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

Directions:

Shake well – adults and children 12 year of age and older: spray product on affected area, not more than 3 to 4 times daily. – children under 12 years of age: consult a doctor.

Indication & Usage

temporarily relief of pain and itching associated with

arthritis simple backache muscle strains bruises cramps muscle sprains

Otc Purpose Section

temporarily relief of pain and itching associated with:

arthritis • simple backache • muscle strains • bruises • cramps • muscle sprains

Inactive Ingredients:

Glycerin, propylene Glycol, SD Alcohol 40 (58%), USP grade purified Water.

Active Ingredient Purpose

Menthol 16% Topical analgesic

Otc Keep Out of Reach of Children

Keep out of reach of the children. If swallowed, get medical help or contact a Poison Control Center right away

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

Cool 'n Heat, 16% Menthol/pain Relieving Spray


Structured Label Content

Uses

Temporality alleviates minor aches and pains of muscles and joints associated with Arthritis, Simple Backache, Strains, Bruises, or Sprains

Warnings:

For external use only.

Flammable: Do not use while smoking or near heat or flames. Avoid long term storage

above 104°F. Do not puncture or incinerate. Contents under pressure. Do not store at temperatures above 120°F.

When using this product avoid contact with eyes and mucous membranes. Do not apply to wounds or damaged skin. Do not bandage tightly. Use only as directed.

Stop use and ask doctor if condition worsens or symptoms persist for more than 7 days or clear up and occur again within a few days. Do not use for longer than 1 week.

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center immediately.

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

Directions:

Shake well – adults and children 12 year of age and older: spray product on affected area, not more than 3 to 4 times daily. – children under 12 years of age: consult a doctor.

Indication & Usage

temporarily relief of pain and itching associated with

arthritis simple backache muscle strains bruises cramps muscle sprains

Otc Purpose Section (OTC Purpose Section)

temporarily relief of pain and itching associated with:

arthritis • simple backache • muscle strains • bruises • cramps • muscle sprains

Inactive Ingredients: (Inactive ingredients:)

Glycerin, propylene Glycol, SD Alcohol 40 (58%), USP grade purified Water.

Active Ingredient Purpose (ACTIVE INGREDIENT PURPOSE)

Menthol 16% Topical analgesic

Dosage and Administration

Shake well

adults and children 12 years of age and older spray on affected area not more than 3 to 4 times daily

children under 12 years of age consult a doctor

Otc Keep Out of Reach of Children (OTC - Keep Out of Reach of Children)

Keep out of reach of the children. If swallowed, get medical help or contact a Poison Control Center right away

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

Cool 'n Heat, 16% Menthol/pain Relieving Spray (Cool 'n heat, 16% Menthol/Pain relieving Spray)


Advanced Ingredient Data


Raw Label Data

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