SAFE CLEANER HAND SANITIZER GEL- alcohol gel 
S ONE pharmaceutical 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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74721-0001

Alcohol

water, carbomer, etc

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

keep out of reach of the children

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.

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

Do not use

When using this product keep out of eyes, ears, and mouth. In case of contact with eyes, rinse 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. If swallowed, get medical help or contact a Poison Control Center right away.

for external use only

label

100ml NDC: 74721-0001-2 Label

250ml NDC: 74721-0001-3 Label

300ml NDC: 74721-0001-4 Label 475ml NDC: 74721-0001-5 Label

1000ml NDC: 74721-0001-6 Label

1000ml NDC: 74721-0001-7 Label

2000ml NDC: 74721-0001-8 Label

4000ml NDC: 74721-0001-9 Label

2ml NDC: 74721-0001-0 Label

SAFE CLEANER HAND SANITIZER GEL 
alcohol gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:74721-0001
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL350 mL  in 500 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:74721-0001-1500 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product04/06/2020
2NDC:74721-0001-2100 mL in 1 BOTTLE; Type 0: Not a Combination Product06/05/2020
3NDC:74721-0001-3250 mL in 1 BOTTLE; Type 0: Not a Combination Product06/05/2020
4NDC:74721-0001-4300 mL in 1 BOTTLE; Type 0: Not a Combination Product06/05/2020
5NDC:74721-0001-5475 mL in 1 BOTTLE; Type 0: Not a Combination Product06/05/2020
6NDC:74721-0001-61000 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product06/05/2020
7NDC:74721-0001-71000 mL in 1 BOTTLE; Type 0: Not a Combination Product06/05/2020
8NDC:74721-0001-82000 mL in 1 BOTTLE; Type 0: Not a Combination Product06/05/2020
9NDC:74721-0001-94000 mL in 1 BOTTLE; Type 0: Not a Combination Product06/05/2020
10NDC:74721-0001-02 mL in 1 POUCH; Type 0: Not a Combination Product06/10/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A04/06/2020
Labeler - S ONE pharmaceutical inc. (694626932)
Registrant - S ONE pharmaceutical inc. (694626932)
Establishment
NameAddressID/FEIBusiness Operations
S ONE pharmaceutical inc.694626932manufacture(74721-0001) , label(74721-0001) , pack(74721-0001)

Revised: 6/2020
Document Id: a7b52a3d-995e-7304-e053-2a95a90a0b69
Set id: a2c0e052-5c37-1951-e053-2995a90a32ec
Version: 3
Effective Time: 20200610
 
S ONE pharmaceutical inc.