HAND SANITIZER- alcohol gel 
Broncolin, 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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Herbacil Hand Sanitizer

Active Ingredient

Alcohol 70%

Purpose

Antiseptic

Use

■ To decrease bacteria on the skin that could cause disease. Recommended for repeated use.

Warnings

Flammable. Keep away from fire & flame. For external use hands only

When using this product

■ Keep out of eyes. In case of contact with eyes, flush thoroughly with water ■ Avoid contact with broken skin ■ Do not inhale or ingest

Stop use and ask a doctor if

■ irritation or redness develops ■ conditions persist for more than 72 hours ■ redness is present

Keep out of reach of children

In case of accidental ingestion, contact a doctor or Poison Control Center immediately.

Directions

■ Wet hands throughhly with product,and allow to dry without wiping ■ For children under 6, use only with adult supervision ■ Not recommended for infants

Other information

■ Do not store above105ºF ■ May discolor some fabrics ■ Harmful to wood finishes and plastics

Inactive Ingredients

carbomer, glycerin, triethanolamine, water

Package Label

Package Label

HAND SANITIZER 
alcohol gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:62583-020
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL70 mL  in 100 mL
Inactive Ingredients
Ingredient NameStrength
GLYCERIN (UNII: PDC6A3C0OX)  
TROLAMINE (UNII: 9O3K93S3TK)  
WATER (UNII: 059QF0KO0R)  
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:62583-020-42125 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product04/03/2020
2NDC:62583-020-08250 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product04/14/2020
3NDC:62583-020-16500 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product04/14/2020
4NDC:62583-020-331000 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product04/14/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A04/03/2020
Labeler - Broncolin, S.A. de C.V (812946390)

Revised: 4/2020
Document Id: a3be5bf7-3a65-2300-e053-2995a90a8a34
Set id: a2ba4bff-d704-fe05-e053-2995a90a387c
Version: 2
Effective Time: 20200420
 
Broncolin, S.A. de C.V