FDA.reportPublic FDA data

Swan_Simply U 248.001/248AI

Manufacturer
Nice-Pak Products, LLC
Effective date
2026-09-14
Label type
HUMAN OTC DRUG LABEL
Version
14
Source
daily-update
Hydrated at
2026-09-18 01:00:42

Label at a glance#

ProductChest Rub
Active ingredientCAMPHOR (SYNTHETIC), EUCALYPTUS OIL, MENTHOL
Label structure19 sections

Indications and uses

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

Dosage and administration

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

Storage and handling

store at room temperature

Label contents#

Full prescribing information#

Warning

WARNINGS AND PRECAUTIONS SECTION

Failure to follow these warnings could result in serious consequences

Active ingredients

OTC - ACTIVE INGREDIENT SECTION

Camphor 4.8%

Eucalyptus oil 1.2%

Menthol 2.6%

Purpose

OTC - PURPOSE SECTION

Cough suppressant & topical analgesic

Uses

INDICATIONS & USAGE SECTION

  • on chest & throat, temporarily relieves cough due to the common cold
  • on muscles and joints, temporarily relieves 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
  • with tight bandages
  • in nostrils
  • on wounds or damaged skin

Ask a doctor before use if you have

OTC - ASK DOCTOR SECTION

  • 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

OTC - WHEN USING SECTION

  • 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

OTC - STOP USE SECTION

  • 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,

OTC - PREGNANCY OR BREAST FEEDING SECTION

ask a health professional before use.

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

Directions

DOSAGE & ADMINISTRATION SECTION

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 information

STORAGE AND HANDLING SECTION

  • store at room temperature

Inactive ingredients

INACTIVE INGREDIENT SECTION

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

Claims

SPL UNCLASSIFIED SECTION

The active ingredients in SimplyU  Chest Rub work naturally to relieve coughing due to colds when you breathe in the medicated vapors.

Disclaimer

SPL UNCLASSIFIED SECTION

*This product is not manufactured or distributed by Procter & Gamble, distributor of Vicks® VapoRub®.

Adverse reaction

ADVERSE REACTIONS SECTION

Distributed by: Nice-Pak Products, LLC

8800 Page Ave.

St. Louis, MO 63114

1-888-593-0593

Principal panel display

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Swan

Chest Rub

COUGH SUPPRESSANT

TOPICAL ANALGESIC

Compare to Vicks ®VapoRub ®*

NET WT 1.76 OZ (50 g)

image descriptionimage description

Principal panel display

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

*Compare to Vicks ®

SIMPLY U  ®

CHEST RUB

COUGH SUPPRESSANT

TOPICAL ANALGESIC

NET WT 3.53 OZ (100 g)

image descriptionimage description

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
Data codeData MatrixL0022723CAmm02.jpg

Products#

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

DailyMed product names page 1 of 1 · 10 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
11344-24811344-248-75, 11344-248-17

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 8 matching rows.

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

Source Document#

Source XML

Older Hydrated Versions#

Version, Effective date, Source table
VersionEffective dateSourceHydrated
132026-03-12full-release2026-06-01 01:50:16

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
4cd7bea5-eb5a-45a5-e063-6394a90ae717ece10fdf-51f0-49ec-b38a-83f20203e0d82026-03-12Warnings, Adverse reactionsExact identifier
spl set id: ece10fdf-51f0-49ec-b38a-83f20203e0d8

Reported adverse events (FAERS/openFDA)#

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