ONE STEP- hand sanitizer gel

ONE STEP by

Drug Labeling and Warnings

ONE STEP by is a Otc medication manufactured, distributed, or labeled by BELVEDERE INTERNATIONAL INC.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredient

Ethyl Alcohol 70%v/v .........Antiseptic

Uses

Hand sanitizer to help reduce bacteria on the skin

Warnings

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

For external use only.

STOP USE

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

WHEN USING

When using this product avoid contact with eyes. if contact occurs, rinse thoroughly with water.

KEEP OUT OF REACH OF CHILDREN

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

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.

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).

OTHER SAFETY INFORMATION

Store at a temperature below 110 F (43 oC)

may discolor certain fabrics or surfaces.

DOSAGE & ADMINISTRATION

Children under 6 years should be supervised when using this product

PRINCIPAL DISPLAY PANEL

PRINCIPAL DISPLAY PANEL

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

ONE STEP 
hand sanitizer gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 60742-400
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
EDETOL (UNII: Q4R969U9FR)
CARBOMER 940 (UNII: 4Q93RCW27E)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
POLYSORBATE 20 (UNII: 7T1F30V5YH)
EXT. D&C VIOLET NO. 2 (UNII: G5UX3K0728)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 60742-400-03	473 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	02/03/2020
2	NDC: 60742-400-01	60 mL in 1 BOTTLE; Type 0: Not a Combination Product	02/03/2020
3	NDC: 60742-400-04	236 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	02/03/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333E	02/03/2020

Labeler - BELVEDERE INTERNATIONAL INC. (247836356)

Registrant - BELVEDERE INTERNATIONAL INC. (247836356)

Establishment
Name	Address	ID/FEI	Business Operations
BELVEDERE INTERNATIONAL INC.		247836356	manufacture(60742-400)