HAND SANITIZER  70 PERCENT- ethyl alcohol solution 
AmmMm, 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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AmmMm ALCOHOL HAND SANITIZER GEL - 70% Ethyl Alcohol (77397-101)

Active ingredient

Ethyl Alcohol 70%

PURPOSE

ANTIBACTERIAL

FUNCTION:

70% Alcohol Hand Sanitizers, kill 99.9% of the bacteria on hands with 2.5 ml of solution for 15 seconds after application.

Warnings

FOR EXTERNAL USE ONLY - HANDS

KEEP AWAY FROM HEAT, FIRE OR FLAME.

WHEN USING THIS PRODUCT: AVOID CONTACT WITH EYES. IN CASE OF EYE CONTACT, FLUSH WITH THOROUGHLY WATER. AVOID CONTACT WITH BROKEN SKIN AND AVOID SWALLOW.

STOP USE AND ASK A DOCTOR: IF IRRITATION OR REDNESS DEVELOPS OR IF CONDITION 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

Inactive ingredients

WATER, GLYCERIN, PROPYLENE GLYCOL, CARBOMER, AMINOMETHYL PROPANOL

OTHER INFORMATION:

01b LBL_Hand sanitizer

HAND SANITIZER   70 PERCENT
ethyl alcohol solution
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:77397-101
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
WATER (UNII: 059QF0KO0R)  
GLYCERIN (UNII: PDC6A3C0OX)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)  
AMINOMETHYLPROPANOL (UNII: LU49E6626Q)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:77397-101-11500 mL in 1 BOTTLE; Type 0: Not a Combination Product05/06/2020
2NDC:77397-101-123785 mL in 1 BOTTLE; Type 0: Not a Combination Product08/04/2020
3NDC:77397-101-131000 mL in 1 BOTTLE; Type 0: Not a Combination Product08/08/2020
4NDC:77397-101-14236 mL in 1 BOTTLE; Type 0: Not a Combination Product08/08/2020
5NDC:77397-101-15118 mL in 1 BOTTLE; Type 0: Not a Combination Product08/08/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333E05/06/2020
Labeler - AmmMm, Inc. (808060680)

Revised: 1/2022
Document Id: d5d1e72c-4c2b-e036-e053-2a95a90ac9aa
Set id: 35ac3bbf-d614-4118-80b8-c0d4ebd0160b
Version: 9
Effective Time: 20220117
 
AmmMm, Inc.