FDA.reportPublic FDA data

TheraCare Medicated Chest Rub

Manufacturer
Veridian Healthcare | Jell Pharmaceuticals Private Limited
Effective date
2024-10-29
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-06-01 00:31:47

Label at a glance#

ProductTheraCare Medicated Chest Rub
Active ingredientCAMPHOR (SYNTHETIC), EUCALYPTUS OIL, MENTHOL
Label structure8 sections

Indications and uses

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

Dosage and administration

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

store at room temperature

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredients

OTC - ACTIVE INGREDIENT SECTION

Camphor 4.8%

Eucalyptus oil 1.2%

Menthol 2.6%

Purpose

OTC - PURPOSE SECTION

Camphor 4.8% Cough suppressant, topical analgesic

Menthol 2.6% Cough suppressant, topical analgesic

Eucalyptus oil 1.2% Cough suppressant

Uses

INDICATIONS & USAGE SECTION

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

Warnings

WARNINGS SECTION

For external use only; avoid contact with eyes.

Do not use

OTC - DO NOT USE SECTION

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

Ask a doctor before use if you have

OTC - ASK DOCTOR SECTION

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

When using this product, do not

OTC - WHEN USING SECTION

  • heat
  • 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

OTC - STOP USE SECTION

  • 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.

OTC - PREGNANCY OR BREAST FEEDING SECTION

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

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children. In case of accidental ingestion, get medical help or contact a Poison Control Center (800-222-1222) right away.

Directions

DOSAGE & ADMINISTRATION SECTION

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

Other information

STORAGE AND HANDLING SECTION

  • store at room temperature

Inactive ingredients

INACTIVE INGREDIENT SECTION

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

PRINCIPAL DISPLAY PANEL - 113 g

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

labellabel

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
727137camphor 4.8 % / eucalyptus oil 1.2 % / menthol 2.6 % Topical OintmentPSN3
727137camphor 0.048 MG/MG / Eucalyptus oil 0.012 MG/MG / menthol 0.026 MG/MG Topical OintmentSCD3
727137camphor 4.8 % / eucalyptus oil 1.2 % / menthol 2.6 % Chest RubSY3
727137camphor 4.8 % / eucalyptus oil 1.2 % / menthol 2.6 % Topical OintmentSY3

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71101-200-01TheraCare Medicated Chest Rub1 in 1 BOXOINTMENT13
71101-200-01TheraCare Medicated Chest Rub113 g in 1 JAROINTMENT1133

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71101-200THERACARE MEDICATED CHEST RUB (CAMPHOR (SYNTHETIC), EUCALYPTUS OIL, AND MENTHOL) OINTMENT [VERIDIAN HEALTHCARE]3Current NDC, Legacy NDC, 2 package rows20241031_d6e789c7-a55a-dc9a-e053-2a95a90a2bdb.zip

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 11 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
71101-20071101-200-01

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 9 matching rows.

Name, UNII, Kind table
NameUNIIKind
PARAFFINI9O0E3H2ZEIACT
CEDAR LEAF OILBJ169U4NLGIACT
NUTMEG OILZ1CLM48948IACT
THYMOL3J50XA376EIACT
TURPENTINE OILC5H0QJ6V7FIACT
PETROLATUM4T6H12BN9UIACT
CAMPHOR (SYNTHETIC)5TJD82A1ETACTIB
EUCALYPTUS OIL2R04ONI662ACTIB
MENTHOLL7T10EIP3AACTIB

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
TheraCare Medicated Chest RubCAMPHOR (SYNTHETIC), EUCALYPTUS OIL, AND MENTHOLVeridian Healthcared6e789c7-a55a-dc9a-e053-2a95a90a2bdb2024-10-29WarningsExact identifier
ndc (package): 71101-200-01
ndc (product): 71101-200
ndc11 (package): 71101020001
spl id: 25a33d70-a34e-c69b-e063-6294a90a014f
spl set id: d6e789c7-a55a-dc9a-e053-2a95a90a2bdb

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.