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GoodSense Medicated Chest Rub

GoodSense Medicated Chest Rub

Approved
Approval ID

240bb6af-9d38-49fe-9011-3016246b0986

Product Type

HUMAN OTC DRUG LABEL

Effective Date

Sep 23, 2025

Manufacturers
FDA

GOOD SENSE

DUNS: 076059836

Products 1

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

Camphor (synthetic), Eucalyptus oil, and Menthol

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code50804-205
Application NumberM012
Product Classification
M
Marketing Category
C200263
G
Generic Name
Camphor (synthetic), Eucalyptus oil, and Menthol
Product Specifications
Route of AdministrationTOPICAL
Effective DateSeptember 23, 2025
FDA Product Classification

INGREDIENTS (9)

PARAFFINInactive
Code: I9O0E3H2ZE
Classification: IACT
CEDAR LEAF OILInactive
Code: BJ169U4NLG
Classification: IACT
NUTMEG OILInactive
Code: Z1CLM48948
Classification: IACT
THYMOLInactive
Code: 3J50XA376E
Classification: IACT
TURPENTINE OILInactive
Code: C5H0QJ6V7F
Classification: IACT
PETROLATUMInactive
Code: 4T6H12BN9U
Classification: IACT
CAMPHOR (SYNTHETIC)Active
Quantity: 0.048 g in 1 g
Code: 5TJD82A1ET
Classification: ACTIB
EUCALYPTUS OILActive
Quantity: 0.012 g in 1 g
Code: 2R04ONI662
Classification: ACTIB
MENTHOLActive
Quantity: 0.026 g in 1 g
Code: L7T10EIP3A
Classification: ACTIB

Drug Labeling Information

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LOINC: 51945-4Updated: 9/23/2025

PRINCIPAL DISPLAY PANEL

label

INDICATIONS & USAGE SECTION

LOINC: 34067-9Updated: 9/23/2025

Uses

  • Temporarily relieves throat and chest
  • cough
  • nasal congestion due to common cold
  • aching muscles
  • minor aches and pains

SPL UNCLASSIFIED SECTION

LOINC: 42229-5Updated: 9/23/2025

Drug Facts

OTC - ACTIVE INGREDIENT SECTION

LOINC: 55106-9Updated: 9/23/2025

Active ingredients

Camphor 4.8%

Eucalyptus oil 1.2%

Menthol 2.6%

Purpose

Camphor 4.8% Cough suppressant, topical analgesic

Menthol 2.6% Cough suppressant, topical analgesic

Eucalyptus oil 1.2% Cough suppressant

WARNINGS SECTION

LOINC: 34071-1Updated: 9/23/2025

Warnings

**For external use only;**avoid contact with eyes.

Do not use

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

Ask a doctor before use if you have

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

When using this product, do not

heat,m microwave, use near open flame, add to hot water or any container where heating water may cause splattering and result in burns

Stop use and ask a doctor if

  • muscle aches/pain persist more than 7 days or comes back
  • cough lasts more than 7 days or comes back, or occurs with fever, rash, or headache that lasts. 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. In case of accidental ingestion, get medical help orcontact a Poison Control Center (800-222-1222) right away.

DOSAGE & ADMINISTRATION SECTION

LOINC: 34068-7Updated: 9/23/2025

Directions

see important warnings under "When using this product"

*children under 2 years of age, ask a doctor before using this product

adults and children 2 years and over:

  • rub a thick layer on chest & fractor rub on sore aching muscles. If desired cover with a dry soft cloth but keep clothing loose. Repeat up to 3 times daily

STORAGE AND HANDLING SECTION

LOINC: 44425-7Updated: 9/23/2025

Other information

store at room temperature

INACTIVE INGREDIENT SECTION

LOINC: 51727-6Updated: 9/23/2025

Inactive ingredients

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

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GoodSense Medicated Chest Rub - FDA Drug Approval Details