SPL v1
SPL
SPL Set ID 69c0b9e3-e02a-1c1e-e053-2991aa0aaf4a
Route
TOPICAL
Published
Effective Date 2018-04-13
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 (1.2 g)
Inactive Ingredients
Cedar Leaf Oil Nutmeg Methylparaben Petrolatum Thymol Turpentine Propylparaben

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH FINAL Active Since 2018-04-09

Description

Camphor 4.7% Menthol 1.25% Eucalyptus Oil 1.2%

Purpose

Cough suppressant & topical analgesic Cough suppressant Cough suppressant & topical anlagesic


Medication Information

Purpose

Cough suppressant & topical analgesic

Cough suppressant

Cough suppressant & topical anlagesic

Description

Camphor 4.7% Menthol 1.25% Eucalyptus Oil 1.2%

Uses

■ when applied to chest or throat temporarily relieves cough due to minor throat and bronchial irritation associated with the common cold ■ when applied to muscles and joints, temporarily relieves minor aches and pains of muscles and joints

Warnings

For external use only; avoid contact with eyes.

Directions

see important warnings under "When using this product"

■ adults and children 2 years and over: ■ adults for cough supression ■ rub a thick layer on throat & chest. ■ cover with a wrm dry cloth if desired ■ keep clothing loose around throat and chest to help vapors reach the nose and mouth ■ use up to three times daily or as directed by a doctor ■ for muscle joint minor aches and pains apply to affected area not more than 3 to 4 times daily ■​ children under 2 years do not use

Do Not Use

■ by mouth ■ with tight bandages ■ in nostrils ■​ on wounds or damaged skin

Package Label

Other Information

■​ store at room temperature

Active Ingredients

Camphor 4.7%

Menthol 1.25%

Eucalyptus Oil 1.2%



Inactive Ingredients

cedar leaf oil, methylparaben, nutmeg oil, petrolatum, propylparaben,thymol, turpentine oil

Stop Use and Ask A Doctor If

■ muscle aches and pains persist for 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. If pregnant or breast-feeding, ask a health professional before use

Keep Out of Reach of Children

If swallowed, get medical help or contact a Poison Control Center iright away.

When Using This Product, Do Not

heat ■ microwave ■ add to hot water or any container where heating water. May cause splattering and result in burns

Ask A Doctor Before Use If You Have

■ cough that occurs with too much phlegm (mucus) ■​ persistent or chronic cough such as occurs with emoking, asthma or emphysema


Structured Label Content

Uses

■ when applied to chest or throat temporarily relieves cough due to minor throat and bronchial irritation associated with the common cold ■ when applied to muscles and joints, temporarily relieves minor aches and pains of muscles and joints

Purpose

Cough suppressant & topical analgesic

Cough suppressant

Cough suppressant & topical anlagesic

Warnings

For external use only; avoid contact with eyes.

Directions

see important warnings under "When using this product"

■ adults and children 2 years and over: ■ adults for cough supression ■ rub a thick layer on throat & chest. ■ cover with a wrm dry cloth if desired ■ keep clothing loose around throat and chest to help vapors reach the nose and mouth ■ use up to three times daily or as directed by a doctor ■ for muscle joint minor aches and pains apply to affected area not more than 3 to 4 times daily ■​ children under 2 years do not use

Do Not Use (Do not use)

■ by mouth ■ with tight bandages ■ in nostrils ■​ on wounds or damaged skin

Package Label

Other Information (Other information)

■​ store at room temperature

Active Ingredients (Active ingredients)

Camphor 4.7%

Menthol 1.25%

Eucalyptus Oil 1.2%



Inactive Ingredients (Inactive ingredients)

cedar leaf oil, methylparaben, nutmeg oil, petrolatum, propylparaben,thymol, turpentine oil

Stop Use and Ask A Doctor If (Stop use and ask a doctor if)

■ muscle aches and pains persist for 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. If pregnant or breast-feeding, ask a health professional before use

Keep Out of Reach of Children (Keep out of reach of children)

If swallowed, get medical help or contact a Poison Control Center iright away.

When Using This Product, Do Not (When using this product, do not)

heat ■ microwave ■ add to hot water or any container where heating water. May cause splattering and result in burns

Ask A Doctor Before Use If You Have (Ask a doctor before use if you have)

■ cough that occurs with too much phlegm (mucus) ■​ persistent or chronic cough such as occurs with emoking, asthma or emphysema


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)