FRESH PROTECT HAND SANITIZER BERGAMONT LIME- alcohol gel 
Willspeed Technologies 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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Fresh Protect Gel Scented Pump

Fresh Protect Gel Scented

Drug Facts

Active Ingredients

Ethyl Alcohol 80% v/v

Purpose

Antimicrobial

Uses

- hand sanitizing to help reduce bacteria that potentially can cause disease. For use when soap and water are not available.

Warnings

For external use only. Do not drink.

Flammable. Keep away from heat and flame

Do not use

on children less than 2 years of age. - 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.

Directions

- Place enough product on hands to cover all surfaces - supervised children under 6 years of age when using this product to avoid swallowing.

Other information

- store at 15C to 30C (59F to 86F) - Avoid freezing and excessive heat above 40C (104F)

Inactive Ingredients

Water, Ammonium Acryloyldimethltaurate/VP Copolymer, Citrus Sinensis Peel Oil expressed, Citrus Aurantium Bergamia (Bergamot Peel Oil, Citrus Aurantifolia (Lime) Oil, Aloe Barbadensis Leaf Juice, Niacinamide, Hydrogen Peroxide, Maltodextrin, Tocopheryl Acetate, DL-Panthenol

PRINCIPAL DISPLAY PANEL

Fresh
PROTECT
HAND SANITIZER GEL
80% ALCOHOL
Non-sterile solution

PRINCIPAL DISPLAY PANEL
Fresh
PROTECT
HAND SANITIZER GEL
80% ALCOHOL
Non-sterile solution

FRESH PROTECT HAND SANITIZER  BERGAMONT LIME
alcohol gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69243-0110
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL0.8 g  in 1 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
AMMONIUM ACRYLOYLDIMETHYLTAURATE/VP COPOLYMER (UNII: W59H9296ZG)  
ORANGE OIL TERPENELESS (UNII: L8B7EWV9I7)  
BERGAMOT OIL (UNII: 39W1PKE3JI)  
LIME OIL (UNII: UZH29XGA8G)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
NIACINAMIDE (UNII: 25X51I8RD4)  
HYDROGEN PEROXIDE (UNII: BBX060AN9V)  
MALTODEXTRIN (UNII: 7CVR7L4A2D)  
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
PANTHENOL (UNII: WV9CM0O67Z)  
Product Characteristics
Color    Score    
ShapeSize
FlavorLIME (Bergamot Lime) Imprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:69243-0110-159 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product08/13/2020
2NDC:69243-0110-2118 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product08/13/2020
3NDC:69243-0110-3237 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product08/13/2020
4NDC:69243-0110-4355 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product08/13/2020
5NDC:69243-0110-5473 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product08/13/2020
6NDC:69243-0110-6946 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product08/13/2020
7NDC:69243-0110-71893 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product08/13/2020
8NDC:69243-0110-83785 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product08/13/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH NOT FINALpart35608/13/2020
Labeler - Willspeed Technologies LLC (019063540)

Revised: 8/2020
Document Id: e4485f18-51d7-4295-97d7-3c46bf860a70
Set id: 441f2f63-bbeb-402c-9b15-e42d640c5c8c
Version: 1
Effective Time: 20200818
 
Willspeed Technologies LLC