ONE STEP- alcohol gel 
Belvedere International Inc.

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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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.

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.

• 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

473 ml label60 ml label236 ml label

ONE STEP 
alcohol gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:60742-300
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL62 mL  in 100 mL
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:60742-300-0160 mL in 1 BOTTLE; Type 0: Not a Combination Product02/01/2019
2NDC:60742-300-04236 mL in 1 BOTTLE; Type 0: Not a Combination Product02/01/2019
3NDC:60742-300-03473 mL in 1 BOTTLE; Type 0: Not a Combination Product02/01/2019
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35602/01/2019
Labeler - Belvedere International Inc. (247836356)
Registrant - BELVEDERE INTERNATIONAL INC. (247836356)
Establishment
NameAddressID/FEIBusiness Operations
Belvedere International Inc.247836356manufacture(60742-300)

Revised: 2/2019
Document Id: 82d20659-1883-354c-e053-2a91aa0acc8a
Set id: 82d1f12a-975e-7c19-e053-2991aa0a20a1
Version: 1
Effective Time: 20190201
 
Belvedere International Inc.