One Step by Belvedere International Inc. / BELVEDERE INTERNATIONAL INC. ONE STEP- alcohol gel

One Step by

Drug Labeling and Warnings

One Step by is a Otc medication manufactured, distributed, or labeled by Belvedere International Inc., BELVEDERE INTERNATIONAL INC.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Ethyl Alcohol 70% v/v

Uses

Hand Sanitizer to help reduce bacteria on the skin

Keep out of reach of children

Keep out of reach of children

Directions

place enough product in your palm to thoroughly cover your

hands and rub hands together until dry.

children under 6 years should be supervised when using this

product.

WARNINGS

Flammable. Keep away from source of heat, fire or flame.

For external use only.

When using this product avoid contact with eyes. If contact

occurs, rinse thoroughly with water.

Stop use and ask a doctor if irritation or redness develops and

lasts.

Keep out of reach of children. If swallowed, get medical help

or contact a Poison Control Center immediately.

DOSAGE & ADMINISTRATION

place enough product in your palm to thoroughly cover your

hands and rub hands together until dry.

children under 6 years should be supervised when using this

product.

Inactive Ingredients

Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Aloe Barbadensis Leaf Extract, Ext. Violet 2 (CI 60730), Fragrance (Parfum), Polysorbate 20, Tetrahydroxypropyl Ethylenediamine, Water (Aqua).

packaging label

INGREDIENTS AND APPEARANCE

ONE STEP 
alcohol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 60742-300
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	62 mL  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
POLYSORBATE 20 (UNII: 7T1F30V5YH)
EXT. D&C VIOLET NO. 2 (UNII: G5UX3K0728)
CARBOMER HOMOPOLYMER TYPE C (UNII: 4Q93RCW27E)
EDETOL (UNII: Q4R969U9FR)
ALOE VERA LEAF (UNII: ZY81Z83H0X)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 60742-300-01	60 mL in 1 BOTTLE; Type 0: Not a Combination Product	02/01/2019
2	NDC: 60742-300-04	236 mL in 1 BOTTLE; Type 0: Not a Combination Product	02/01/2019
3	NDC: 60742-300-03	473 mL in 1 BOTTLE; Type 0: Not a Combination Product	02/01/2019

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part356	02/01/2019

Labeler - Belvedere International Inc. (247836356)

Registrant - BELVEDERE INTERNATIONAL INC. (247836356)

Establishment
Name	Address	ID/FEI	Business Operations
Belvedere International Inc.		247836356	manufacture(60742-300)