vapozol chest rub

vapozol chest rub
SPL v5
SPL
SPL Set ID bfe0affe-9e6f-6f57-e053-2a95a90a49e5
Route
topical
Published
Effective Date 2021-03-29
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
menthol, unspecified form (18 mg)
Inactive Ingredients
eucalyptus oil camphor (synthetic) white petrolatum nutmeg oil

Identifiers & Packaging

Marketing Status
otc monograph drug active Since 2019-03-29

Purpose

Cough Suppressant & Topical Analgesic

Description

Menthol 1.8%


Medication Information

Warnings

For external use only • Avoid contact with the eyes. Do not use • by mouth • with tight bandages • in nostrils • on wounds or damaged skin • Do not use if safety seal is torn, broken or missing.

Uses

Uses • on chest and throat, temporarily relieves cough due to the common cold. • on muscles and joints, temporarily relieves minor aches and pains.

Indications and Usage

When using this product, do not • heat n microwave • add to hot water or any container where heating water may cause splattering and result in burns.

Purpose

Cough Suppressant & Topical Analgesic

Directions

Directions • see important warnings under “When using this product” • adults and children 2 years and over; • rub a thick layer on chest & throat or rub on sore aching muscles • cover with a warm, dry cloth if desired • keep clothing loose about throat/chest to help vapors reach the nose/mouth • repeat up to three times per 24 hours or as directed by doctor • not intended for use by persons under the age of 18.

Other Information

Store at controlled room temperature 15-30ºC (59-86ºF)

Inactive Ingredients

White petrolatum, camphor, eucalyptus oil, nutmeg oil.

Description

Menthol 1.8%

Section 50569-3

Stop use and ask a doctor if • muscle aches and pains persist more than 7 days or come back • cough lasts more than 7 days, comes back, or occurs with fever, rash, or persistent headache. These could be signs of a serious condition. • pregnant or breastfeeding.

Ask a doctor before use if you have n cough that occurs with too much phlegm (mucus) n persistent or chronic cough such as occurs with smoking, asthma or emphysema.

Section 51945-4

Section 53414-9

Stop use and ask a doctor if pregnant or breastfeeding.

Active Ingredient

Menthol 1.8%


Structured Label Content

Warnings

For external use only • Avoid contact with the eyes. Do not use • by mouth • with tight bandages • in nostrils • on wounds or damaged skin • Do not use if safety seal is torn, broken or missing.

Uses

Uses • on chest and throat, temporarily relieves cough due to the common cold. • on muscles and joints, temporarily relieves minor aches and pains.

Indications and Usage (34067-9)

When using this product, do not • heat n microwave • add to hot water or any container where heating water may cause splattering and result in burns.

Purpose

Cough Suppressant & Topical Analgesic

Directions

Directions • see important warnings under “When using this product” • adults and children 2 years and over; • rub a thick layer on chest & throat or rub on sore aching muscles • cover with a warm, dry cloth if desired • keep clothing loose about throat/chest to help vapors reach the nose/mouth • repeat up to three times per 24 hours or as directed by doctor • not intended for use by persons under the age of 18.

Other Information

Store at controlled room temperature 15-30ºC (59-86ºF)

Inactive Ingredients

White petrolatum, camphor, eucalyptus oil, nutmeg oil.

Section 50569-3 (50569-3)

Stop use and ask a doctor if • muscle aches and pains persist more than 7 days or come back • cough lasts more than 7 days, comes back, or occurs with fever, rash, or persistent headache. These could be signs of a serious condition. • pregnant or breastfeeding.

Ask a doctor before use if you have n cough that occurs with too much phlegm (mucus) n persistent or chronic cough such as occurs with smoking, asthma or emphysema.

Section 51945-4 (51945-4)

Section 53414-9 (53414-9)

Stop use and ask a doctor if pregnant or breastfeeding.

Active Ingredient

Menthol 1.8%


Advanced Ingredient Data


Raw Label Data

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