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Vaporizing Chest Rub by Universal Distribution Center LLC

Medically reviewed on Dec 26, 2017

Dosage form: gel
Ingredients: CAMPHOR (SYNTHETIC) 4.7g in 100g, MENTHOL 1g in 100g, EUCALYPTUS OIL 1g in 100g
Labeler: Universal Distribution Center LLC
NDC Code: 52000-012

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Active Ingredients

Camphor            4.7%

Menthol             1.0%

Eucalyptus Oil   1.0%

Purpose

Decongestant

Uses

  • on chest and throat, helps temporarily relive cough due to common cold.
  • on joints and muscles, temporarily relives minor aches and pains.

Warnings

For external use only; avoid contact with eyes.

Do not use

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

Ask doctor before use if you have,

  • cough that occurs with too much phlegm (mucus)
  • persistent or chronic cough such as occurs with asthma, emphysema, or smoking

When using this product, do not

  • heat
  • microwave
  • add to hot water or any container where heating water. May cause splattering and results in burns

Stop use and ask a doctor if

  • cough lasts more than 7 days, comes back, or occurs with fever, rash or persistent headache. These could be signs of a serious conditions
  • muscle aches or pain persist more than 7 days or come back

Keep out of the reach of children

If ingested get medical help or contact a Poison control center immediately

Directions

  • adults and children 2 years and over
  • rub a thick layer on chest and throat or rub on sore aching muscles
  • keep clothing loose around chest/throat to help vapors reach the nose/mouth

  • repeat up to 3 times per 24 hours or as directed by doctor
  • do not use on children under 2 years unless directed by doctor

Inactive ingredients

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

PRINCIPAL DISPLAY PANEL

VAPORISING CHEST RUB
NASAL DECONGESTANT AND COUGH SUPPRESSANT
NET WT.4 OZ (113g)



VAPORIZING CHEST RUB 
menthol and camphor and eucalyptus oil gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:52000-012
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CAMPHOR (SYNTHETIC) (CAMPHOR (SYNTHETIC)) CAMPHOR (SYNTHETIC)4.7 g  in 100 g
MENTHOL (MENTHOL) MENTHOL1 g  in 100 g
EUCALYPTUS OIL (EUCALYPTUS OIL) EUCALYPTUS OIL1 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
CEDAR LEAF OIL 
NUTMEG OIL 
MINERAL OIL 
PETROLATUM 
THYMOL 
TURPENTINE OIL 
Packaging
#Item CodePackage Description
1NDC:52000-012-0850 g in 1 BOTTLE, PLASTIC
2NDC:52000-012-0956.6 g in 1 BOTTLE, PLASTIC
3NDC:52000-012-10100 g in 1 BOTTLE, PLASTIC
4NDC:52000-012-11113 g in 1 BOTTLE, PLASTIC
5NDC:52000-012-12150 g in 1 BOTTLE, PLASTIC
6NDC:52000-012-13170 g in 1 BOTTLE, PLASTIC
7NDC:52000-012-14226 g in 1 BOTTLE, PLASTIC
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34103/15/2013
Labeler - Universal Distribution Center LLC (019180459)
Registrant - Anicare Pharmaceuticals Pvt. Ltd (916837425)
Establishment
NameAddressID/FEIOperations
Jell Pharmaceuticals Pvt. Ltd.726025211manufacture(52000-012)
Establishment
NameAddressID/FEIOperations
Anicare Pharmaceuticals Pvt. Ltd916837425manufacture(52000-012)

 
Universal Distribution Center LLC

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Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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