BRONCO RUB- camphor eucalyptus menthol ointment 
Distribuidora de Alimentos Naturales y Nutricionales, S.A. de C.V

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.

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Active Ingredients

Camphor 4.8%

Eucalyptus 1.2%

Menthol 2.6%

Purpose

Cough Suppressant/Topical Anlagesic

Cough Suppressant

Cough Suppressant/Topical Anlagesic

Uses

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

Warnings

For external use only. Avoid contact with eyes.

Do not use

• by mouth or in nostrils • with tight bandages • 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 • use near an open flame • 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 worsen, persist for more than 7 days or come back within a few days • 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

If swallowed get medical help or contact a Poison Control Center immediately.

Directions

see important warnings under "When using this product" section

•adults and children 2 years and over rub a thick layer on chest and 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: do not use

Other information

• store at room temperature

Inactive ingredients

Petrolatum and Turpentine oil

Package label

image description

BRONCO RUB 
camphor eucalyptus menthol ointment
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:66513-220
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET) (CAMPHOR (SYNTHETIC) - UNII:5TJD82A1ET) CAMPHOR (SYNTHETIC)4.8 g  in 100 g
EUCALYPTUS OIL (UNII: 2R04ONI662) (EUCALYPTUS OIL - UNII:2R04ONI662) EUCALYPTUS OIL1.2 g  in 100 g
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL2.6 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
PETROLATUM (UNII: 4T6H12BN9U)  
TURPENTINE OIL (UNII: C5H0QJ6V7F)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:66513-220-1439 g in 1 JAR; Type 0: Not a Combination Product08/15/2014
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalM01208/15/2014
Labeler - Distribuidora de Alimentos Naturales y Nutricionales, S.A. de C.V (814400404)
Establishment
NameAddressID/FEIBusiness Operations
Distribuidora de Alimentos Naturales y Nutricionales, S.A. de C.V814400404manufacture(66513-220)

Revised: 10/2022
Document Id: eb017336-7b4d-7039-e053-2995a90a6a2c
Set id: 3deba53b-fd26-46c8-87b4-1962ba13779d
Version: 3
Effective Time: 20221014
 
Distribuidora de Alimentos Naturales y Nutricionales, S.A. de C.V