Universal Vaporizing Chest Rub

Universal Vaporizing Chest Rub
SPL v2
SPL
SPL Set ID b1d25572-da21-408d-aab3-3a0741dfff12
Route
TOPICAL
Published
Effective Date 2020-06-08
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Camphor (synthetic) (4.7 g) Menthol (1.25 g) Eucalyptus Oil (1.0 g)
Inactive Ingredients
Cedar Leaf Oil Nutmeg Oil Paraffin Petrolatum Thymol Turpentine Oil

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2020-06-16

Description

Active Ingredients Camphor            4.7% Menthol             1.25% Eucalyptus Oil   1.0%


Medication Information

Warnings and Precautions

Warnings

For external use only; avoid contact with eyes.

Indications and Usage

Uses

  • on chest and throat, helps temporarily relive cough due to common cold.
  • on joints and muscles, temporarily relives minor aches and pains.
Dosage and Administration

Directions

Adults and Children 2 years and over

  • rub a thick layer on chest and throat or rub on sore aching muscles
  • keep clothing loose around chest/throat to help vapors reach the nose/mouth
  • repeat up to 3 times per 24 hours or as directed by doctor

Children under 2 years: do not use on unless directed by doctor

Description

Active Ingredients Camphor            4.7% Menthol             1.25% Eucalyptus Oil   1.0%

Section 50565-1

Keep out of the reach of children

If ingested get medical help or contact a Poison control center immediately

Section 50566-9

Stop use and ask a doctor if

  • cough lasts more than 7 days, comes back, or occurs with fever, rash or persistent headache. These could be signs of a serious conditions
  • muscle aches or pain persist more than 7 days or come back
Section 50567-7

When using this product, do not

  • heat
  • microwave
  • add to hot water or any container where heating water. May cause splattering and results in burns
Section 50569-3

Ask doctor before use if you have,

  • cough that occurs with too much phlegm (mucus)
  • persistent or chronic cough such as occurs with asthma, emphysema, or smoking
Section 50570-1

Do not use

  • by mouth
  • in nostrils
  • with tight bandages
  • on wounds or damaged skin
Section 51727-6

Inactive ingredients

cedar leaf oil, nutmeg oil, paraffin, petrolatum, thymol, turpentine oil

Section 51945-4

PRINCIPAL DISPLAY PANEL

UNIVERSAL VAPORISING CHEST RUB

NASAL DECONGESTANT AND COUGH SUPPRESSANT

NET WT.4 OZ (113g)

Section 55105-1

Purpose

Decongestant

Section 55106-9

Active Ingredients

Camphor            4.7%

Menthol             1.25%

Eucalyptus Oil   1.0%


Structured Label Content

Indications and Usage (34067-9)

Uses

  • on chest and throat, helps temporarily relive cough due to common cold.
  • on joints and muscles, temporarily relives minor aches and pains.
Dosage and Administration (34068-7)

Directions

Adults and Children 2 years and over

  • rub a thick layer on chest and throat or rub on sore aching muscles
  • keep clothing loose around chest/throat to help vapors reach the nose/mouth
  • repeat up to 3 times per 24 hours or as directed by doctor

Children under 2 years: do not use on unless directed by doctor

Warnings and Precautions (34071-1)

Warnings

For external use only; avoid contact with eyes.

Section 50565-1 (50565-1)

Keep out of the reach of children

If ingested get medical help or contact a Poison control center immediately

Section 50566-9 (50566-9)

Stop use and ask a doctor if

  • cough lasts more than 7 days, comes back, or occurs with fever, rash or persistent headache. These could be signs of a serious conditions
  • muscle aches or pain persist more than 7 days or come back
Section 50567-7 (50567-7)

When using this product, do not

  • heat
  • microwave
  • add to hot water or any container where heating water. May cause splattering and results in burns
Section 50569-3 (50569-3)

Ask doctor before use if you have,

  • cough that occurs with too much phlegm (mucus)
  • persistent or chronic cough such as occurs with asthma, emphysema, or smoking
Section 50570-1 (50570-1)

Do not use

  • by mouth
  • in nostrils
  • with tight bandages
  • on wounds or damaged skin
Section 51727-6 (51727-6)

Inactive ingredients

cedar leaf oil, nutmeg oil, paraffin, petrolatum, thymol, turpentine oil

Section 51945-4 (51945-4)

PRINCIPAL DISPLAY PANEL

UNIVERSAL VAPORISING CHEST RUB

NASAL DECONGESTANT AND COUGH SUPPRESSANT

NET WT.4 OZ (113g)

Section 55105-1 (55105-1)

Purpose

Decongestant

Section 55106-9 (55106-9)

Active Ingredients

Camphor            4.7%

Menthol             1.25%

Eucalyptus Oil   1.0%


Advanced Ingredient Data


Raw Label Data

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