HAND SANITIZER- alcohol gel

Hand Sanitizer by

Drug Labeling and Warnings

Hand Sanitizer by is a Otc medication manufactured, distributed, or labeled by Broncolin, S.A. de C.V. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

INGREDIENTS AND APPEARANCE

HAND SANITIZER 
alcohol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 62583-020
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	70 mL  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
GLYCERIN (UNII: PDC6A3C0OX)
TROLAMINE (UNII: 9O3K93S3TK)
WATER (UNII: 059QF0KO0R)
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 62583-020-42	125 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	04/03/2020
2	NDC: 62583-020-08	250 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	04/14/2020
3	NDC: 62583-020-16	500 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	04/14/2020
4	NDC: 62583-020-33	1000 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	04/14/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	04/03/2020

Labeler - Broncolin, S.A. de C.V (812946390)