SPASOAP- hand sanitizer liquid 
Sante Manufacturing 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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Active Ingredients

Ethyl Alcohol 70%

Purpose - Antiseptic

Use hand sanitizer to help reduce bacteria on the skin

Warnings

Flammable

Keep away from fire or flame

For external use only

When using this product do not use in or near eyes. In case of contact, rinse eyes thoroughly with water

Keep out of reach of children

If swallowed, get medical help or contact a Poison Control Center right away

Directions

Water, Carbomer, Trethanolamine, Glycerin, Propylene Glycol, Alo Barbdensis Leaf Juice*, Tocopherol Acetate*, Lavandula Angustifolia Flower / Leaf / Stem Extract*, Fragrance*, D&C Red # 33*, FD&C Blue # 1*, FD&C Yellow # 5*,

* Contains 1 or more of these ingredients

Spa Soap Hand Sanitizer​SpaSoap

Hand Sanitizer

2fl.oz (59ml) Each

6 fl.oz (177ml) Total

SPASOAP 
hand sanitizer liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71020-015
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL700 mL  in 1000 mL
Inactive Ingredients
Ingredient NameStrength
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
LAVANDULA ANGUSTIFOLIA WHOLE (UNII: 51217XIL5L)  
WATER (UNII: 059QF0KO0R)  
CARBOMER 940 (UNII: 4Q93RCW27E)  
GLYCERIN (UNII: PDC6A3C0OX)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
D&C RED NO. 33 (UNII: 9DBA0SBB0L)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:71020-015-02177 mL in 1 PACKAGE, COMBINATION; Type 1: Convenience Kit of Co-Package03/11/2017
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A03/11/2017
Labeler - Sante Manufacturing Inc (242048747)
Establishment
NameAddressID/FEIBusiness Operations
Sante Manufacturing Inc242048747manufacture(71020-015)

Revised: 3/2017
Document Id: 4a77f5e6-7269-0cdb-e054-00144ff8d46c
Set id: 4a70eac0-f696-3f8c-e054-00144ff8d46c
Version: 2
Effective Time: 20170311
 
Sante Manufacturing Inc