ADVANCED HAND SANITIZER- benzalkonium chloride gel 
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.

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Drug Facts

Active Ingredients

Benzalkonium Chloride 0.13%

Purpose

Antimicrobial

Use

Hand sanitizer to help reduce bacteria on the skin that can cause disease.

Warnings

For external use only.

When using this product avoid contact with the eyes. In case of contact, rinse eyes thoroughly with water.

Stop use and ask a doctor if irritation and redness appears and lasts

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

Directions

Apply liberally to front and back of hands. Allow to dry. Repeat daily.

Other Information

Store above 0°C (32°F)

Inactive Ingredients

Aloe Barbadensis Leaf Juice, Caesalpinia Spinosa Gum, Ethylhexylglycerin, Glycerin, Phenoxyethanol, Purified Water

Safe +
Palms

ADVANCED
HAND SANITIZER

NON-ALCOHOL

Gel Formula

Kills 99.99% of Germs
and Bacteria

Hypoallergenic
Patented Formula

MADE IN
USA

16 fl oz (480ml) • safepalms.com

Package Label
ADVANCED HAND SANITIZER 
benzalkonium chloride gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:90117-201
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE0.13 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
CAESALPINIA SPINOSA RESIN (UNII: WL3883U2PO)  
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
GLYCERIN (UNII: PDC6A3C0OX)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
WATER (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:90117-201-0160 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product08/25/2020
2NDC:90117-201-02118 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product08/25/2020
3NDC:90117-201-03237 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product08/25/2020
4NDC:90117-201-04480 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product08/25/2020
5NDC:90117-201-05946 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product08/25/2020
6NDC:90117-201-061892 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product08/25/2020
7NDC:90117-201-073785 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(90117-201)

Revised: 8/2020
Document Id: 9b4b0d0e-b4db-4ec7-a9a1-2d4582dc0af5
Set id: 095de23a-21d6-416c-8bf5-c882179f2ccf
Version: 2
Effective Time: 20200825
 
Safe Palms, LLC