Vaporizing Cold Rub

SPL v27

SPL

SPL Set ID 3ed8bc0c-c229-450b-a491-06b578c1b8ee

Route

TOPICAL

Published

Effective Date 2024-06-17

Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients

Menthol (2.6 g) Eucalyptus Oil (1.2 g) Camphor (synthetic) (4.73 g)

Inactive Ingredients

Petrolatum Cedar Leaf Oil Thymol Turpentine

Identifiers & Packaging

Pill Appearance

Color: blue

Marketing Status

OTC MONOGRAPH DRUG Completed Since 2011-05-24 Until 2022-10-20

Description

Camphor 4.7% Eucalyptus oil 1.2% Menthol 2.6%

Purpose

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

Medication Information

Purpose

Cough suppressant & topical analgesic

Cough suppressant

Cough suppressant & topical analgesic

Description

Camphor 4.7% Eucalyptus oil 1.2% Menthol 2.6%

Uses

temporarily relieves:

cough due to minor bronchial irritation associated with a cold or inhaled irritants
cough associated with a cold
minor aches and pains of muscles and joints

Section 50565-1

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

Section 53414-9

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

Pii 4 Oz

Warnings

For external use only; avoid contact with eyes.

Directions

see important warnings under "When using this product"
adults and children 2 years and older:
rub on the throat and chest in a thick layer
cover with a warm, dry cloth if desired
clothing should be loose about throat and chest to help vapors reach the nose and mouth
use up to three times daily or as directed by a doctor
children under 2 years of age: ask a doctor

Penetro4oz

Do Not Use:

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

Penetro1.75oz

Other Information

store at room temperature

Penetro 4oz Label

Active Ingredients

Camphor 4.7%

Eucalyptus oil 1.2%

Menthol 2.6%

Inactive Ingredients

cedar leaf oil, petrolatum, thymol, turpentine

Penetro 1.75 Oz Label

Stop Use and Ask A Doctor If

muscle aches and pains worsen or persist for more than 7 days or clear up and occur again within a few days
cough perists for more than 1 week, tends to recur, or is accompanied by fever, rash, or persistent headache. A persistent cough may be a sign of a serious condition.

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

excessive phlegm (mucus)
emphysema
persistent or chronic cough
asthma
cough associated with smoking

Structured Label Content

Uses

temporarily relieves:

cough due to minor bronchial irritation associated with a cold or inhaled irritants
cough associated with a cold
minor aches and pains of muscles and joints

Section 50565-1 (50565-1)

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

Section 53414-9 (53414-9)

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

Purpose

Cough suppressant & topical analgesic

Cough suppressant

Cough suppressant & topical analgesic

Pii 4 Oz (PII 4 OZ)

Warnings

For external use only; avoid contact with eyes.

Directions

see important warnings under "When using this product"
adults and children 2 years and older:
rub on the throat and chest in a thick layer
cover with a warm, dry cloth if desired
clothing should be loose about throat and chest to help vapors reach the nose and mouth
use up to three times daily or as directed by a doctor
children under 2 years of age: ask a doctor

Penetro4oz

Do Not Use: (Do not use:)

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

Penetro1.75oz

Other Information (Other information)

store at room temperature

Penetro 4oz Label

Active Ingredients (Active ingredients)

Camphor 4.7%

Eucalyptus oil 1.2%

Menthol 2.6%

Inactive Ingredients (Inactive ingredients)

cedar leaf oil, petrolatum, thymol, turpentine

Penetro 1.75 Oz Label (Penetro 1.75 oz Label)

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

muscle aches and pains worsen or persist for more than 7 days or clear up and occur again within a few days
cough perists for more than 1 week, tends to recur, or is accompanied by fever, rash, or persistent headache. A persistent cough may be a sign of a serious condition.

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)

excessive phlegm (mucus)
emphysema
persistent or chronic cough
asthma
cough associated with smoking

Advanced Ingredient Data

[{"name": "PETROLATUM", "unii": "4T6H12BN9U", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "CEDAR LEAF OIL", "unii": "BJ169U4NLG", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "THYMOL", "unii": "3J50XA376E", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "TURPENTINE", "unii": "XJ6RUH0O4G", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "MENTHOL", "unii": "L7T10EIP3A", "classCode": "ACTIB", "strengthNumerator": "2.6", "strengthDenominator": "100", "strengthNumeratorUnit": "g", "strengthDenominatorUnit": "g"}, {"name": "EUCALYPTUS OIL", "unii": "2R04ONI662", "classCode": "ACTIB", "strengthNumerator": "1.2", "strengthDenominator": "100", "strengthNumeratorUnit": "g", "strengthDenominatorUnit": "g"}, {"name": "CAMPHOR (SYNTHETIC)", "unii": "5TJD82A1ET", "classCode": "ACTIB", "strengthNumerator": "4.73", "strengthDenominator": "100", "strengthNumeratorUnit": "g", "strengthDenominatorUnit": "g"}]

Raw Label Data

All Sections (JSON)

{"Uses": "temporarily relieves: cough due to minor bronchial irritation associated with a cold or inhaled irritants cough associated with a cold minor aches and pains of muscles and joints", "50565-1": "Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.", "53414-9": "If pregnant or breast-feeding, ask a health professional before use.", "Purpose": "Cough suppressant & topical analgesic Cough suppressant Cough suppressant & topical analgesic", "Warnings": "For external use only; avoid contact with eyes.", "Directions": "see important warnings under "When using this product" adults and children 2 years and older: rub on the throat and chest in a thick layer cover with a warm, dry cloth if desired clothing should be loose about throat and chest to help vapors reach the nose and mouth use up to three times daily or as directed by a doctor children under 2 years of age: ask a doctor", "Do not use:": "by mouth on wounds or damaged skin in nostrils with tight bandages", "Other information": "store at room temperature", "Active ingredients": "Camphor 4.7% Eucalyptus oil 1.2% Menthol 2.6%", "Inactive ingredients": "cedar leaf oil, petrolatum, thymol, turpentine", "Stop use and ask a doctor if": "muscle aches and pains worsen or persist for more than 7 days or clear up and occur again within a few days cough perists for more than 1 week, tends to recur, or is accompanied by fever, rash, or persistent headache. A persistent cough may be a sign of a serious condition.", "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": "excessive phlegm (mucus) emphysema persistent or chronic cough asthma cough associated with smoking"}

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:05:31.516736 · Updated: 2026-03-14T23:13:05.198485