Warning
Failure to follow these warnings could result in serious consequences
Chest Rub Jelly
FDA Label NDC 11344-248
18 label sections · Submitted to the FDA by Nice-pak Products, Llc · Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Nice-pak Products, Llc for the product Chest Rub (NDC 11344-248). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding warning, active ingredients, purpose, uses, warnings, do not use, ask a doctor before use if you have, when using this product, do not, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Active Ingredients
Camphor 4.8%
Eucalyptus oil 1.2%
Menthol 2.6%
Purpose
Cough suppressant & topical analgesic
Uses
- on chest & throat, temporarily relieves cough due to the common cold
- on muscles and joints, temporarily relieves minor aches and pains
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.
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 Information
- store at room temperature
Inactive Ingredients
cedarleaf oil, nutmeg oil, special petrolatum, spirits of turpentine, thymol
Claims
The active ingredients in SimplyU Chest Rub work naturally to relieve coughing due to colds when you breathe in the medicated vapors.
Disclaimer
*This product is not manufactured or distributed by Procter & Gamble, distributor of Vicks® VapoRub®.
Adverse Reaction
Distributed by: Nice-Pak Products, LLC
8800 Page Ave.
St. Louis, MO 63114
1-888-593-0593
Principal Panel Display
Swan
Chest Rub
COUGH SUPPRESSANT
TOPICAL ANALGESIC
Compare to Vicks ®VapoRub ®*
NET WT 1.76 OZ (50 g)
Image Description (Mm01)
*Compare to Vicks ®
SIMPLY U ®
CHEST RUB
COUGH SUPPRESSANT
TOPICAL ANALGESIC
NET WT 3.53 OZ (100 g)
Image Description (Mm02)
* Please review the disclaimer below.
