SAFE CLEANER PLUS- alcohol liquid 
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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Active Ingredient

Ethyl alcohol 70%

Purpose

Antimicrobial

Uses

Hand sanitizer to help reduce bacteria on the skin.

Warnings

Flammable. Keep away from fire or flame.

For external use only

When using this product

do not use in or near the eyes.

In case of contact, rinse eyes thoroughly with water.

Stop use and ask a doctor if

irritation or rash appears and lasts.

Keep out of reach of children.

If swallowed, get medical help or contact a Poison Control Center right away.

Directions

* Put enough product in your palm to cover hands and rub hands together briskly until dry.

* Children under 6 years of age should be supervised when using Safe Cleaner Hand Sanitizer.

Other information

* Store below 110F (43C)

* May discolor certain fabrics or surfaces.

Inactive Ingredients

Glycerine, Purified water, Propylene glycol, Carbomer, Triethanolamine, Sophora extract, Grapefruit seed extract, Mentha oil

Package Label

100ml NDC: 74721-0010-4 Label

250ml NDC: 74721-0010-5 Label

475ml NDC: 74721-0010-6 Label

1000ml NDC: 74721-0010-7 Label

2000ml NDC: 74721-0010-8 Label

4000ml NDC: 74721-0010-9 Label

500ml NDC: 74721-0010-1 Label500ml NDC: 74721-0010-2 Label

SAFE CLEANER PLUS 
alcohol liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:74721-0010
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL70 mL  in 100 mL
Inactive Ingredients
Ingredient NameStrength
TROLAMINE (UNII: 9O3K93S3TK)  
SOPHORA FLAVESCENS ROOT (UNII: IYR6K8KQ5K)  
CITRUS PARADISI SEED (UNII: 12F08874Y7)  
WATER (UNII: 059QF0KO0R)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)  
PEPPERMINT OIL (UNII: AV092KU4JH)  
GLYCERIN (UNII: PDC6A3C0OX)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:74721-0010-4100 mL in 1 BOTTLE; Type 0: Not a Combination Product05/24/2020
2NDC:74721-0010-5250 mL in 1 BOTTLE; Type 0: Not a Combination Product05/24/2020
3NDC:74721-0010-6475 mL in 1 BOTTLE; Type 0: Not a Combination Product05/24/2020
4NDC:74721-0010-71000 mL in 1 BOTTLE; Type 0: Not a Combination Product05/24/2020
5NDC:74721-0010-82000 mL in 1 BOTTLE; Type 0: Not a Combination Product05/24/2020
6NDC:74721-0010-94000 mL in 1 BOTTLE; Type 0: Not a Combination Product05/24/2020
7NDC:74721-0010-1500 mL in 1 BOTTLE; Type 0: Not a Combination Product05/28/2020
8NDC:74721-0010-2500 mL in 1 BOTTLE; Type 0: Not a Combination Product05/28/202006/10/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A05/24/2020
Labeler - S-ONE PHARMACEUTICAL INC (694626932)
Registrant - S-ONE PHARMACEUTICAL INC (694626932)
Establishment
NameAddressID/FEIBusiness Operations
S-ONE PHARMACEUTICAL INC694626932manufacture(74721-0010)

Revised: 6/2020
Document Id: a7b13beb-3226-171a-e053-2995a90a3594
Set id: a64d73c4-81f7-0232-e053-2a95a90a3027
Version: 3
Effective Time: 20200609
 
S-ONE PHARMACEUTICAL INC