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Medicated Chest Rub

Rexall 248.001/248AI Medicated Chest Rub

Approved
Approval ID

7855033e-6a12-4cd8-b0a2-c5d69018d117

Product Type

HUMAN OTC DRUG LABEL

Effective Date

Aug 12, 2025

Manufacturers
FDA

Old East Main CO.

DUNS: 068331990

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 Code55910-248
Application NumberM012
Product Classification
M
Marketing Category
C200263
G
Generic Name
Camphor, Eucalyptus Oil, Menthol
Product Specifications
Route of AdministrationTOPICAL
Effective DateAugust 12, 2025
FDA Product Classification

INGREDIENTS (8)

CEDAR LEAF OILInactive
Code: BJ169U4NLG
Classification: IACT
NUTMEG OILInactive
Code: Z1CLM48948
Classification: IACT
PETROLATUMInactive
Code: 4T6H12BN9U
Classification: IACT
TURPENTINE OILInactive
Code: C5H0QJ6V7F
Classification: IACT
THYMOLInactive
Code: 3J50XA376E
Classification: IACT
CAMPHOR (SYNTHETIC)Active
Quantity: 4.8 kg in 100 kg
Code: 5TJD82A1ET
Classification: ACTIB
EUCALYPTUS OILActive
Quantity: 1.2 kg in 100 kg
Code: 2R04ONI662
Classification: ACTIB
MENTHOLActive
Quantity: 2.6 kg in 100 kg
Code: L7T10EIP3A
Classification: ACTIB

Drug Labeling Information

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LOINC: 51945-4Updated: 8/12/2025

principal display panel

Since 1903

REXALL ®

Medicated Chest Rub

  • Cough suppressant
  • Topical analgesic

NET WT 3.53 OZ (100 g)

image description

INDICATIONS & USAGE SECTION

LOINC: 34067-9Updated: 8/12/2025

Uses

  • on chest & throat, temporarily relieves cough due to the common cold
  • on muscles and joints, temporarily relieves minor aches and pains

ADVERSE REACTIONS SECTION

LOINC: 34084-4Updated: 8/12/2025

ADVERSE REACTION

Visit us at: Rexall.com or call 1-866-4-REXALL

DISTRIBUTED BY OLD EAST MAIN CO.

100 MISSION RIDGE

GOODLETTSVILLE, TN 37072

Since 1903 Rexall is a registered trademark of Rexall Sundown, Inc.

OTC - ACTIVE INGREDIENT SECTION

LOINC: 55106-9Updated: 8/12/2025

Active ingredients

Camphor 4.8%

Eucalyptus oil 1.2%

Menthol 2.6%

OTC - PURPOSE SECTION

LOINC: 55105-1Updated: 8/12/2025

Purpose

Cough suppressant + topical analgesic

SPL UNCLASSIFIED SECTION

LOINC: 42229-5Updated: 8/12/2025

Disclaimer

Failure to follow these warnings could result in serious consequences.

WARNINGS SECTION

LOINC: 34071-1Updated: 8/12/2025

Warnings

For external use only; avoid contact with eyes.

Do not use

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

Ask a doctor before use if you have

  • cough that occurs with too much phlegm (mucus)
  • persistent or chronic cough such as 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 result in burns.

Stop use and ask a doctor if

  • muscle aches and pains persist 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.

In case of accidental ingestion, get medical help or contact a Poison Control Center right away.

DOSAGE & ADMINISTRATION SECTION

LOINC: 34068-7Updated: 8/12/2025

Directions

See important warnings under "When using this product"

  • adults & children 2 yrs & over:
  • rub a thick layer on chest & throat or rub on sore aching muscles
  • cover with a warm, dry cloth if desired
  • keep clothing loose about throat/chest to help vapors reach the nose/mouth
  • repeat up to three times per 24 hours or as directed by doctor
  • children under 2 years of age: ask a doctor

OTHER SAFETY INFORMATION

LOINC: 60561-8Updated: 8/12/2025

Other information

  • store at room temperature

INACTIVE INGREDIENT SECTION

LOINC: 51727-6Updated: 8/12/2025

Inactive ingredients

cedarleaf oil, nutmeg oil, special petrolatum, spirits of turpentine, thymol

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Medicated Chest Rub - FDA Drug Approval Details