ADVANCED HAND SANITIZER- alcohol liquid 
Safe Palms, 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.

----------

Drug Facts

Active Ingredients

Ethyl Alcohol 70%

Purpose

Antibacterial

Use

For rinse-free hand sanitizing to remove 99.9% bacteria on skin

Warnings

Flammable. Keep away from fire or flame. For external use only.

When using this product

Do not use in eyes. In case of contact with eyes, rinse with water.

Stop use and ask a doctor if irritation and redness develop and persist.

Keep out of reach of children.

If swallowed, get medical help promptly.

Directions

Wet hands thoroughly with product and allow to dry without wiping.

Other Information

Store under 105°F

Inactive Ingredients

Aloe Barbadensis Leaf Juice, Glycerin, Lemon Essential Oil, Purified Water, Tocopheryl Acetate (Vitamin E)

Safe +
Palms

ADVANCED
HAND SANITIZER

70% Alcohol

Liquid Formula

Kills 99.99% of Germs
and Bacteria

Hypoallergenic
Patented Formula

MADE IN
USA

LEMON SCENTED

16 fl oz (480ml) • safepalms.com

Package Label
ADVANCED HAND SANITIZER 
alcohol liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:90117-101
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
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
GLYCERIN (UNII: PDC6A3C0OX)  
WATER (UNII: 059QF0KO0R)  
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
Lemon Oil (UNII: I9GRO824LL)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:90117-101-0160 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product08/25/2020
2NDC:90117-101-02118 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product08/25/2020
3NDC:90117-101-03237 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product08/25/2020
4NDC:90117-101-04480 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product08/25/2020
5NDC:90117-101-05946 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product08/25/2020
6NDC:90117-101-061892 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product08/25/2020
7NDC:90117-101-073785 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product08/25/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A08/25/2020
Labeler - Safe Palms, LLC (117609055)
Establishment
NameAddressID/FEIBusiness Operations
Music City Laboratories, Llc117409349MANUFACTURE(90117-101)

Revised: 8/2020
Document Id: 9b7dca35-088c-4263-aa9d-0051d3a9ec66
Set id: 7eb58314-0c1d-44e5-80a7-a829c7b4cfb5
Version: 2
Effective Time: 20200825
 
Safe Palms, LLC