STRATA HAND SANITIZER- isopropyl alcohol 75% gel IMPULSE ANTIBACTERIAL HAND SANITIZER- isopropyl alcohol 75% gel

Impulse Antibacterial Hand Sanitizer by

Drug Labeling and Warnings

Impulse Antibacterial Hand Sanitizer by is a Otc medication manufactured, distributed, or labeled by Strata USA LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

DOSAGE & ADMINISTRATION

Directions:Wet hands thoroughly with product and allow to dry without wiping. For Children under 6, use only under aduplt supervision. Not recommended for infants. Instrucciones: Mojebien las manos con el producto y deje secar sin limpiar. Para niños de 6 años, use solo bajo la supervisión de un adulto. No recomendado para bebés

PURPOSE

Antimicrobial

ACTIVE INGREDIENT

Isopropyl Alcohol 75%

INACTIVE INGREDIENT

Deionized water (Acqua), Aloe Vera, Carbomer, Triethanolamine, Glycerin, Vitamin E

INDICATIONS & USAGE

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

WARNINGS

For External Use Only.

For Professional Use Only. Keep out of reach of children. Para uso externo. Para uso profesional solamente.Mantener fuera del
alcance do los niños. Pour usage externe. Réservé à un usage professionnel. Tenir hors de portée des enfants. Solo per uso esterno. Solo per uso professionale tenere lontano dalla portata dei bambini

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 and redness develop and condition persists for more than 72 hours. If swallowed, get medical help or contact a Poison Control Center right away. Flammable: Keep away from fire or flame.

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children

Strata 77004-204-27 4oz 118 ml

NDC77004-20425 0.5 oz 14.78 ml

INGREDIENTS AND APPEARANCE

STRATA HAND SANITIZER 
isopropyl alcohol 75% gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 77004-204
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	75 mL  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
CARBOMER 940 (UNII: 4Q93RCW27E)	0.3 mL  in 100 mL
ALOE VERA LEAF (UNII: ZY81Z83H0X)	0.2 mL  in 100 mL
GLYCERIN (UNII: PDC6A3C0OX)	0.1 mL  in 100 mL
WATER (UNII: 059QF0KO0R)	24 mL  in 100 mL
TROLAMINE (UNII: 9O3K93S3TK)	0.1 mL  in 100 mL

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 77004-204-25	14.78 mL in 1 POUCH; Type 0: Not a Combination Product	07/01/2020
2	NDC: 77004-204-26	3785 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	07/01/2020
3	NDC: 77004-204-27	118 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	07/01/2020
4	NDC: 77004-204-21	236 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	07/01/2020
5	NDC: 77004-204-22	472 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	07/01/2020
6	NDC: 77004-204-23	944 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	07/01/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	07/01/2020

IMPULSE ANTIBACTERIAL HAND SANITIZER 
isopropyl alcohol 75% gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 77004-205
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	75 mL  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
CARBOMER 940 (UNII: 4Q93RCW27E)	0.3 mL  in 100 mL
ALOE VERA LEAF (UNII: ZY81Z83H0X)	0.2 mL  in 100 mL
GLYCERIN (UNII: PDC6A3C0OX)	0.1 mL  in 100 mL
WATER (UNII: 059QF0KO0R)	24 mL  in 100 mL
TROLAMINE (UNII: 9O3K93S3TK)	0.1 mL  in 100 mL

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 77004-205-25	14.78 mL in 1 POUCH; Type 0: Not a Combination Product	08/01/2020
2	NDC: 77004-205-26	3785 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	08/01/2020
3	NDC: 77004-205-27	118 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	08/01/2020
4	NDC: 77004-205-21	236 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	08/01/2020
5	NDC: 77004-205-22	472 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	08/01/2020
6	NDC: 77004-205-23	944 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	08/01/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	08/01/2020

Labeler - Strata USA LLC (079851683)

Establishment
Name	Address	ID/FEI	Business Operations
Strata USA LLC		079851683	relabel(77004-204)