B-PROTEK- isopropyl alcohol gel

B-Protek by

Drug Labeling and Warnings

B-Protek by is a Otc medication manufactured, distributed, or labeled by Grupo Siller Ingeniería Construcción y Materiales, S.A. de C.V. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredient

Isopropyl Alcohol 80% v/v. 

Purpose

Antiseptic

Use

Hand Sanitizer to help reduce bacteria that potentially can cause disease. For use when soap and water are not available.

Warnings

For external use only. Flammable. Keep away from heat or flame.

Do not mix use with other household chemicals.

Do not use

• in children less than 2 months of age
• on open skin wounds

WHEN USING

When using this product keep out of eyes, ears, and mouth. In case of contact with eyes, rinse eyes thoroughly with water.
Stop use and ask a doctor if irritation or rash occurs. These may be signs of a serious condition.

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Directions

• Place enough product on hands to cover all surfaces. Rub hands together until dry.
• Supervise children under 6 years of age when using this product to avoid swallowing.

Other information

• Store between 15-30C (59-86F)
• Avoid freezing and excessive heat above 40C (104F)

Inactive ingredients

Glycerin, carbomer 940, aloe vera extract, vitamin E, purified water.

Package Label - Principal Display Panel

INGREDIENTS AND APPEARANCE

B-PROTEK 
isopropyl alcohol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 80308-002
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ISOPROPYL ALCOHOL (UNII: ND2M416302) (ISOPROPYL ALCOHOL - UNII:ND2M416302)	ISOPROPYL ALCOHOL	80 mL  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
GLYCERIN (UNII: PDC6A3C0OX)
CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 4Q93RCW27E)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
WATER (UNII: 059QF0KO0R)
.ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)
TROLAMINE (UNII: 9O3K93S3TK)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 80308-002-01	3 mL in 1 POUCH; Type 0: Not a Combination Product	09/24/2020
2	NDC: 80308-002-02	30 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	09/24/2020
3	NDC: 80308-002-03	60 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	09/24/2020
4	NDC: 80308-002-04	250 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	09/24/2020
5	NDC: 80308-002-05	500 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	09/24/2020
6	NDC: 80308-002-06	1000 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	09/24/2020
7	NDC: 80308-002-07	3785 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	09/24/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	09/24/2020

Labeler - Grupo Siller Ingeniería Construcción y Materiales, S.A. de C.V (951577512)

Establishment
Name	Address	ID/FEI	Business Operations
Grupo Siller Ingeniería Construcción y Materiales, S.A. de C.V		951577512	manufacture(80308-002)