SPASOAP- hand sanitizer liquid

SpaSoap by

Drug Labeling and Warnings

SpaSoap by is a Otc medication manufactured, distributed, or labeled by Sante Manufacturing Inc. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active Ingredients

Ethyl Alcohol 70%

PURPOSE

Purpose - Antiseptic

INDICATIONS & USAGE

Use hand sanitizer to help reduce bacteria on the skin

WARNINGS

Warnings

Flammable

OTHER SAFETY INFORMATION

Keep away from fire or flame

INSTRUCTIONS FOR USE

For external use only

WHEN USING

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

Keep out of reach of children

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

DOSAGE & ADMINISTRATION

Directions

• apply palmful to hands
  • rub hands together vigorously until dry
  • supervise children in the use of this product

INACTIVE INGREDIENT

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

PRINCIPAL DISPLAY PANEL

​SpaSoap

Hand Sanitizer

2fl.oz (59ml) Each

6 fl.oz (177ml) Total

INGREDIENTS AND APPEARANCE

SPASOAP 
hand sanitizer liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 71020-015
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	700 mL  in 1000 mL

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 71020-015-02	177 mL in 1 PACKAGE, COMBINATION; Type 1: Convenience Kit of Co-Package	03/11/2017

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	03/11/2017

Labeler - Sante Manufacturing Inc (242048747)

Establishment
Name	Address	ID/FEI	Business Operations
Sante Manufacturing Inc		242048747	manufacture(71020-015)