Cvs Cold And Hot Spray

Cvs Cold And Hot Spray
SPL v4
SPL
SPL Set ID d1676df9-530f-1664-e053-2995a90a5b64
Route
TOPICAL
Published
Effective Date 2022-09-12
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Menthol (16 g)
Inactive Ingredients
Water Glycerin Isobutane Propylene Glycol Dehydrated Alcohol

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Completed Since 2022-09-08 Until 2027-11-30

Description

Menthol 16%


Medication Information

Warnings and Precautions

For external use only

Flammable:

Do not use while smoking or near heat or flames. Avoid longterm storage above 104°F. Do not punctuate or incinerate. Contents under pressure. Do not store at temperatures above 120°F.

Indications and Usage

Temporarily alleviates minor aches and pains of muscles and joints associated with

Arthritis

Simple Backache

Strains

Bruises

Cramps

Dosage and Administration

Directions:

Shake well - adults and children 12 years 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.

Description

Menthol 16%

Section 50565-1

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center immediately (1-800-222-1222).

Section 50566-9

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

Section 50567-7

When using this product use only as directed

Read and follow all directions and warnings on this label

Do not allow contact with eyes and mucous membranes

Rare cases of serious burns have been reported with products of this type

Do not apply to wounds or damaged, broken or irritated skin

Do not bandage or apply local heat (such as heating pads) or medicated patch to the area of use

A transient burning sensation may occur upon application but generally disappears in several days

If severe burning sensations occurs, discontinue use immediately

Do not expose the area treated with product to heat or direct sunlight

Avoid applying into skin folds

Section 51727-6

Glycerin, Isobutane, Propylene Glycol, SD Alcohol 40B (29%), Water

Section 51945-4

Section 53414-9

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

Section 55105-1

Topical analgesic

Section 55106-9

Menthol 16%


Structured Label Content

Indications and Usage (34067-9)

Temporarily alleviates minor aches and pains of muscles and joints associated with

Arthritis

Simple Backache

Strains

Bruises

Cramps

Dosage and Administration (34068-7)

Directions:

Shake well - adults and children 12 years 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.

Warnings and Precautions (34071-1)

For external use only

Flammable:

Do not use while smoking or near heat or flames. Avoid longterm storage above 104°F. Do not punctuate or incinerate. Contents under pressure. Do not store at temperatures above 120°F.

Section 50565-1 (50565-1)

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center immediately (1-800-222-1222).

Section 50566-9 (50566-9)

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

Section 50567-7 (50567-7)

When using this product use only as directed

Read and follow all directions and warnings on this label

Do not allow contact with eyes and mucous membranes

Rare cases of serious burns have been reported with products of this type

Do not apply to wounds or damaged, broken or irritated skin

Do not bandage or apply local heat (such as heating pads) or medicated patch to the area of use

A transient burning sensation may occur upon application but generally disappears in several days

If severe burning sensations occurs, discontinue use immediately

Do not expose the area treated with product to heat or direct sunlight

Avoid applying into skin folds

Section 51727-6 (51727-6)

Glycerin, Isobutane, Propylene Glycol, SD Alcohol 40B (29%), Water

Section 51945-4 (51945-4)

Section 53414-9 (53414-9)

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

Section 55105-1 (55105-1)

Topical analgesic

Section 55106-9 (55106-9)

Menthol 16%


Advanced Ingredient Data


Raw Label Data

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