PROMISE U- promise u 70% ethyl alcohol topical hand sanitizer spray aerosol, spray 
Promise U LLC

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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Promise U 70% Ethyl Alcohol Topical Hand Sanitizer Spray

Active ingredient(s) Ethyl Alcohol 70% v/v

Inactive ingredients: glycerin, hydrogen peroxide, and purified water USP

Purpose.......................................................Antiseptic

Use(s) Health care personnel hand rub to help reduce bacteria that potentially can cause disease.

Spray enough product on hands to cover all surfaces. Rub hands together until dry.

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 at 1-800-222-1222. Supervise children under 6 years of age when using this product to avoid swallowing.

When using this product keep out of eyes, ears, and mouth. In case of contact with eyes, rinse eyes 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 at 1-800-222-1222. For external use only. Flammable. Keep
away from heat or flame. Do not use on children less than 2 months of age and on open skin wounds.

Directions • 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. Other information • Store between 15-30C (59-86F)

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 at 1-800-222-1222.

For external use only. Flammable. Keep away from heat or flame. Do not use on children less than 2 months of age and on open skin
wounds. When using this product keep out of eyes, ears, and mouth. In case of contact with eyes, rinse eyes 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 at 1-800-222-1222.

Supervise children under 6 years of age when using this product to avoid swallowing. Other information • Store between 15-30C (59-86F) • Avoid freezing and excessive heat above 40C (104F)

Promise U's Product Label & Drug Facts

Promise U's Product Label and Drug Facts

PROMISE U 
promise u 70% ethyl alcohol topical hand sanitizer spray aerosol, spray
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:82674-007
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
HYDROGEN PEROXIDE (UNII: BBX060AN9V) 0.125 mL  in 100 mL
GLYCERIN (UNII: PDC6A3C0OX) 1.45 mL  in 100 mL
WATER (UNII: 059QF0KO0R) 28.425 mL  in 100 mL
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:82674-007-011 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product04/01/202012/15/2021
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A04/01/202012/15/2023
Labeler - Promise U LLC (118637295)
Registrant - Promise U Labs (118637295)
Establishment
NameAddressID/FEIBusiness Operations
PROMISE U LLC118637295pack(82674-007)

Revised: 4/2022
Document Id: dc276bcb-9ed8-0be3-e053-2995a90a9753
Set id: dc276bcb-9ed8-0be3-e053-2995a90a9753
Version: 1
Effective Time: 20220408
 
Promise U LLC