Cold Rub
FDA Label NDC 51444-001

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Jmd All Star Impex Inc. for the product Cold Rub (NDC 51444-001). 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 otc - active ingredient, otc - purpose, indications & usage, warnings, otc - do not use, otc - ask doctor, otc - pregnancy or breast feeding, otc - keep out of reach of children, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Otc - Active Ingredient

Active Ingredients
Camphor 4.8%
Eucalyptus oil 1.2%
Menthol 2.8%


Otc - Purpose

PURPOSE

cough suppressant/topical analgesic
nasal decongestant/cough suppressant
cough suppressant/topical analgesic

Indications & Usage

Uses

Temporarily relief for throat and chest

  • Cough 
  • Nasal congestion due to common cold
  • Aching muscles
  • Minor aches and pains

Warnings

WarningFor external use only. Avoid contact with eyes.

Otc - Do Not Use

Do not use
  • by mouth
  • in nostrils
  • on wounds or damaged skin
  • with light bandages

Otc - Ask Doctor

Ask a doctor before use if you have

  • Asthma
  • Excessive phlegm (mucus)
  • Emphysema
  • Persistent or chronic cough
  • Cough associated with smoking

Otc - Pregnancy Or Breast Feeding

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

Otc - Keep Out Of Reach Of Children

Keep out of reach of children. If case of accidental ingestion, get medical help or contact a Poison Control Center immediately.

Dosage & Administration

Directions

  • See important warnings under "When using product"
  • Children under 2 years of age, ask a doctor before using the product
  • Adults and children 2 years of age and older: rub a thick layer chest and throat or sore aching muscles. If desired loosely cover with a soft cloth but keep clothing loose. Repeat up to 3 times daily

Other

Other Information
  • Store at room temperature

Inactive Ingredient

Other IngredientsCedar leaf Oil, Mineral Oil, Nutmeg Oil, Petrolatum, Spirits of Turpentine, Thymol

Package Label.Principal Display Panel

Package Label

Image Of Package Label (Coldrublbl)

Image Of Package Label (Coldrublbl)

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