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Vaporizing chest rub

Approved
Approval ID

065bb666-e482-4e96-ac75-c6577dcc5b48

Product Type

HUMAN OTC DRUG LABEL

Effective Date

Aug 1, 2025

Manufacturers
FDA

LJ Pharma

DUNS: 914078633

Products 1

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

Camphor, Eucalyptus oil, Menthol

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code84809-007
Application NumberM012
Product Classification
M
Marketing Category
C200263
G
Generic Name
Camphor, Eucalyptus oil, Menthol
Product Specifications
Route of AdministrationTOPICAL
Effective DateAugust 1, 2025
FDA Product Classification

INGREDIENTS (8)

CEDAR LEAF OILInactive
Code: BJ169U4NLG
Classification: IACT
NUTMEG OILInactive
Code: Z1CLM48948
Classification: IACT
PETROLATUMInactive
Code: 4T6H12BN9U
Classification: IACT
THYMOLInactive
Code: 3J50XA376E
Classification: IACT
TURPENTINE OILInactive
Code: C5H0QJ6V7F
Classification: IACT
CAMPHOR (NATURAL)Active
Quantity: 4.7 g in 100 g
Code: N20HL7Q941
Classification: ACTIB
EUCALYPTUS OILActive
Quantity: 1.2 g in 100 g
Code: 2R04ONI662
Classification: ACTIB
MENTHOL, UNSPECIFIED FORMActive
Quantity: 1.25 g in 100 g
Code: L7T10EIP3A
Classification: ACTIB

Drug Labeling Information

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LOINC: 51945-4Updated: 7/25/2025

Product label

image description

INDICATIONS & USAGE SECTION

LOINC: 34067-9Updated: 7/25/2025

Uses

When applied to chest or throat: Temporarily relieves cough due to minor throat and bronchial irritation associated with a common cold

When applied to muscles and joints: Temporarily relieves minor aches and pains of muscles and joints

OTC - ACTIVE INGREDIENT SECTION

LOINC: 55106-9Updated: 7/28/2025

Active Ingredient Purpose

Camphor 4.7% Cough suppressant & topical analgesic

Eucalyptus oil 1.2% Cough suppressant

Menthol 1.25% Cough suppressant & topical analgesic

OTC - PURPOSE SECTION

LOINC: 55105-1Updated: 7/25/2025

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

LOINC: 50565-1Updated: 7/25/2025

WARNINGS SECTION

LOINC: 34071-1Updated: 7/28/2025

Warnings

For external use only

Ask a doctor before use if you have:

  • A cough with too much phlegm (mucus)
  • Chronic cough that lasts or occurs with smoking, asthma, or emphysema

When using this product, do not

:

*Heat *Microwave *Add to hot water or any container where heating water may cause splattering and burns

  • Take by mouth or place in nostrils Use in or near eyes
  • Apply to wounds or damaged skin
  • Bandage tightly
  • Use with other topical pain relievers

Stop Use and Ask a Doctor If

  • Muscle aches and pains worsen or last more than 7 days Symptoms clear up and then return within a few days
  • Cough persists more than 1 week, tends to recur, or is accompanied by: Fever, Rash, Persistent headache A persistent cough may be a sign of a serious condition
  • Redness or irritation develops

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 right away.

DOSAGE & ADMINISTRATION SECTION

LOINC: 34068-7Updated: 7/25/2025

Directions

See important warnings under "When using this product" For Cough Suppression:

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 around throat and chest to help vapors reach the nose and mouth

▪ Use up to 3 times daily or as directed by a doctor

Children under 2 years of age:

▪ Ask a doctor

For Muscle & Joint Minor Aches and Pains:

Adults and children 2 years and older:

▪ Clean affected area before applying

▪ Apply to affected area no more than 3 to 4 times daily

Children under 2 years of age:

▪ Consult a doctor

SPL UNCLASSIFIED SECTION

LOINC: 42229-5Updated: 7/25/2025

Other information

  • Store at room temperature

INACTIVE INGREDIENT SECTION

LOINC: 51727-6Updated: 7/25/2025

Inactive Ingredients

Cedar leaf oil, nutmeg oil, petrolatum, thymol, turpentine oil

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Vaporizing chest rub - FDA Drug Approval Details