FDA.reportPublic FDA data

Medicated

Manufacturer
Family Dollar Services Inc | Blue Cross Laboratories | Anicare Pharmaceuticals Pvt. Ltd
Effective date
2012-11-29
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-05-31 22:33:51

Label at a glance#

ProductMedicated Chest Rub
Active ingredientCAMPHOR (SYNTHETIC), MENTHOL, EUCALYPTUS OIL
Label structure15 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Active ingredients
Camphor 4.8%
Menthol 2.6%
Eucalyptus Oil 1.2%

OTC - PURPOSE SECTION

Purpose

Cough suppressant /topical analgesic

Cough suppressant /topical analgesic

Cough supressan

INDICATIONS & USAGE SECTION

Uses: Temporarily relieves throat and chest

  • cough
  • nasal congestion due to common cold
  • aching muscles
  • minor aches and pains

WARNINGS SECTION

Warnings

For external use only. Avoid contact with eyes

OTC - DO NOT USE SECTION

Do not use:

  • by mouth
  • by nostrils
  • on wounds or damaged skin
  • with light bandages

OTC - ASK DOCTOR SECTION

Ask a doctor before use if you have

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

OTC - WHEN USING SECTION

When using this product do not heat
  • microwave
  • use near open flame
  • add to hot water or any container where heating water may cause splattering and result in burns

OTC - STOP USE SECTION

Stop use and ask a doctor if

  • muscle aches/pain persist more than more than 7 days or come back
  • cough lasts more than 7 days, 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 profesional before use

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out reach of children.

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

DOSAGE & ADMINISTRATION SECTION

Directions

  • see important warnings when using this product
  • children under 2 years of age, ask a doctor before using this product
  • adults and children 2 years older, rub a thick layer on chest and and throat or rub on sore,aching muscles. If desired cover with a dry soft cloth but keep clothing loose. Repeat up to 3 times daily

SPL UNCLASSIFIED SECTION

Other information

  • Store at room temperature

INACTIVE INGREDIENT SECTION

Inactive ingredients:

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

SPL UNCLASSIFIED SECTION

image of front labelimage of front label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Medicated chest rub


4 oz (113 g)




image of back label
image of back label

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
55319-100-012020-01-31C16284748780-19d75b9d0-9385-f424-e053-dadaa90a57ceMedicated chest rub

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
55319-100-01MedicatedChest Rub113 g in 1 JARCREAM1132

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55319-100MEDICATED CHEST RUB (CAMPHOR, MENTHOL, EUCALYPTUS OIL) CREAM [FAMILY DOLLAR SERVICES INC]2Legacy NDC, 1 package rows20121130_6f8c45f2-8b47-4696-bd68-d327a48bb21b.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
CAMPHOR (SYNTHETIC)ACTIVE INGREDIENT5TJD82A1ET2
EUCALYPTUS OILACTIVE INGREDIENT2R04ONI6622
MENTHOLACTIVE INGREDIENTL7T10EIP3A2
CAMPHOR (SYNTHETIC)ACTIVE MOIETY5TJD82A1ET2
EUCALYPTUS OILACTIVE MOIETY2R04ONI6622
MENTHOLACTIVE MOIETYL7T10EIP3A2
CEDAR LEAF OILINACTIVE INGREDIENTBJ169U4NLG2
NUTMEG OILINACTIVE INGREDIENTZ1CLM489482
PARAFFININACTIVE INGREDIENTI9O0E3H2ZE2
PETROLATUMINACTIVE INGREDIENT4T6H12BN9U2
THYMOLINACTIVE INGREDIENT3J50XA376E2
TURPENTINEINACTIVE INGREDIENTXJ6RUH0O4G2

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
55319-10055319-100-01

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
CAMPHOR (SYNTHETIC)5TJD82A1ETACTIB
MENTHOLL7T10EIP3AACTIB
EUCALYPTUS OIL2R04ONI662ACTIB
CEDAR LEAF OILBJ169U4NLGIACT
NUTMEG OILZ1CLM48948IACT
PARAFFINI9O0E3H2ZEIACT
PETROLATUM4T6H12BN9UIACT
THYMOL3J50XA376EIACT
TURPENTINEXJ6RUH0O4GIACT

Source Document#

Source XML

Inactive ingredient matches#

Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.

Inactive ingredient links page 1 of 1 · 33 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
PARAFFINPARAFFINI9O0E3H2ZETABLET / ORAL0.7 mgExact identifier — unii candidate
11 equally ranked IID candidates
PETROLATUMPETROLATUM4T6H12BN9USPONGE / TOPICALNAExact identifier — unii candidate
18 equally ranked IID candidates
PARAFFINPARAFFINI9O0E3H2ZESOAP / TOPICAL0.4 %w/wExact identifier — unii candidate
11 equally ranked IID candidates
PETROLATUMPETROLATUM4T6H12BN9ULIQUID / RESPIRATORY (INHALATION)NAExact identifier — unii candidate
18 equally ranked IID candidates
PARAFFINPARAFFINI9O0E3H2ZECAPSULE, EXTENDED RELEASE / ORAL100 mgExact identifier — unii candidate
11 equally ranked IID candidates
PETROLATUMPETROLATUM4T6H12BN9UCAPSULE / VAGINALNAExact identifier — unii candidate
18 equally ranked IID candidates
PETROLATUMPETROLATUM4T6H12BN9UTABLET, EXTENDED RELEASE / ORAL0.18 mgExact identifier — unii candidate
18 equally ranked IID candidates
PETROLATUMPETROLATUM4T6H12BN9UAEROSOL, FOAM / TOPICAL7.9 %w/wExact identifier — unii candidate
18 equally ranked IID candidates
PETROLATUMPETROLATUM4T6H12BN9UOINTMENT / AURICULAR (OTIC)NAExact identifier — unii candidate
18 equally ranked IID candidates
PETROLATUMPETROLATUM4T6H12BN9UCAPSULE, EXTENDED RELEASE / ORAL0.07 mgExact identifier — unii candidate
18 equally ranked IID candidates
THYMOLTHYMOL3J50XA376EPOWDER, FOR SOLUTION / ORALNAExact identifier — unii candidate
2 equally ranked IID candidates
PETROLATUMPETROLATUM4T6H12BN9UOINTMENT / TOPICAL7275 mgExact identifier — unii candidate
18 equally ranked IID candidates
PETROLATUMPETROLATUM4T6H12BN9UEMULSION / TOPICAL7.8 %w/wExact identifier — unii candidate
18 equally ranked IID candidates
PARAFFINPARAFFINI9O0E3H2ZEOINTMENT / RECTAL38 mgExact identifier — unii candidate
11 equally ranked IID candidates
PETROLATUMPETROLATUM4T6H12BN9UTABLET / ORAL3.5 mgExact identifier — unii candidate
18 equally ranked IID candidates
PARAFFINPARAFFINI9O0E3H2ZETABLET, COATED / ORAL0.07 mgExact identifier — unii candidate
11 equally ranked IID candidates
PETROLATUMPETROLATUM4T6H12BN9UCREAM / TOPICAL4213 mgExact identifier — unii candidate
18 equally ranked IID candidates
NUTMEG OILNUTMEG OILZ1CLM48948ELIXIR / ORAL4.5 mg/5mlExact identifier — unii candidate
2 equally ranked IID candidates
PETROLATUMPETROLATUM4T6H12BN9UOINTMENT, AUGMENTED / TOPICAL81.94 %w/wExact identifier — unii candidate
18 equally ranked IID candidates
NUTMEG OILNUTMEG OILZ1CLM48948LIQUID / RESPIRATORY (INHALATION)NAExact identifier — unii candidate
2 equally ranked IID candidates
PARAFFINPARAFFINI9O0E3H2ZEAEROSOL, FOAM / TOPICAL14235 mgExact identifier — unii candidate
11 equally ranked IID candidates
PETROLATUMPETROLATUM4T6H12BN9UOINTMENT / OPHTHALMIC88.4 %w/wExact identifier — unii candidate
18 equally ranked IID candidates
PARAFFINPARAFFINI9O0E3H2ZESUSPENSION / TOPICAL11726 mgExact identifier — unii candidate
11 equally ranked IID candidates
PARAFFINPARAFFINI9O0E3H2ZECREAM / TOPICAL300 mgExact identifier — unii candidate
11 equally ranked IID candidates
PETROLATUMPETROLATUM4T6H12BN9USUPPOSITORY / VAGINAL27 mgExact identifier — unii candidate
18 equally ranked IID candidates
PETROLATUMPETROLATUM4T6H12BN9ULOTION / TOPICAL25 %w/wExact identifier — unii candidate
18 equally ranked IID candidates
PETROLATUMPETROLATUM4T6H12BN9UOINTMENT / VAGINAL4084 mgExact identifier — unii candidate
18 equally ranked IID candidates
PETROLATUMPETROLATUM4T6H12BN9USOAP / TOPICAL0.85 %w/wExact identifier — unii candidate
18 equally ranked IID candidates
PARAFFINPARAFFINI9O0E3H2ZEOINTMENT / TOPICAL2860 mgExact identifier — unii candidate
11 equally ranked IID candidates
THYMOLTHYMOL3J50XA376ELIQUID / RESPIRATORY (INHALATION)0.01 %w/wExact identifier — unii candidate
2 equally ranked IID candidates
PETROLATUMPETROLATUM4T6H12BN9UCREAM, AUGMENTED / TOPICAL26 %w/wExact identifier — unii candidate
18 equally ranked IID candidates
PARAFFINPARAFFINI9O0E3H2ZETABLET, DELAYED RELEASE / ORAL0.2 mgExact identifier — unii candidate
11 equally ranked IID candidates
PARAFFINPARAFFINI9O0E3H2ZETABLET, EXTENDED RELEASE / ORAL321 mgExact identifier — unii candidate
11 equally ranked IID candidates

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
c185f1bf-5c07-4671-ad3b-bb52f07cbe2a6f8c45f2-8b47-4696-bd68-d327a48bb21b2012-11-29WarningsExact identifier
spl id: c185f1bf-5c07-4671-ad3b-bb52f07cbe2a
spl set id: 6f8c45f2-8b47-4696-bd68-d327a48bb21b

Reported adverse events (FAERS/openFDA)#

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