ALCOHOL FOAMING HAND SANITIZER  - alcohol liquid 
Cintas Corp.

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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Drug Facts

Active ingredient                               

Ethyl Alcohol 62%

Uses

For hand sanitizing to decrease bacteria on the skin

Recommended for repeated use

Warnings

Flammable. Keep away from fire or flames.

For external use only.

When using this product avoid contact with eyes. In case of eye contact, flush eyes with water.

Stop use and ask a doctor if irritation or redness develops, or if conditions persists for more than 72 hours.

Keep out of reach of children.

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

Directions:

Wash hands with soap and water

Rinse with potable water

Pump a small amount of foam into palm of hand

Rub thoroughly over all surfaces of both hands

Rub hands together briskly until dry

Other Information:

Store below 110 F (43 C)

May discolor certain fabrics or surfaces

Sanis

Alcohol Foaming

Hand

Sanitizer

800 ML 27.0 FL OZ

container label

Inactive ingredient

DEA-C8-18 perfluoroalkylethyl phosphate, Glycerin, Isopropyl alcohol, Water

Purpose

Antimicrobial

ALCOHOL FOAMING HAND SANITIZER  
alcohol liquid
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:42961-005
Route of Administration TOPICAL DEA Schedule     
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)  
Glycerin (UNII: PDC6A3C0OX)  
ISOPROPYL ALCOHOL (UNII: ND2M416302)  
DIETHANOLAMINE BIS(C8-C18 PERFLUOROALKYLETHYL)PHOSPHATE (UNII: 4J55VM509S)  
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:42961-005-02 800 mL in 1 BOTTLE, PLASTIC
2 NDC:42961-005-06 50 mL in 1 BOTTLE, PLASTIC
3 NDC:42961-005-05 500 mL in 1 BAG
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph not final part333A 12/01/2009
Labeler - Cintas Corp. (056481716)
Establishment
Name Address ID/FEI Business Operations
Natural Essentials Incorporated 947484713 manufacture(42961-005)
Establishment
Name Address ID/FEI Business Operations
Avmor 202107827 manufacture(42961-005)
Establishment
Name Address ID/FEI Business Operations
Best Sanitizers, Inc 627278224 manufacture(42961-005)

Revised: 8/2014
Document Id: c5be1711-2654-481b-a7f1-0fa6f6ccae34
Set id: de7b20a7-af97-48ec-8644-05ecf911a70a
Version: 7
Effective Time: 20140808
 
Cintas Corp.