SEALUXE HAND SANITIZER- ethyl alcohol gel

SeaLuxe Hand Sanitizer by

Drug Labeling and Warnings

SeaLuxe Hand Sanitizer by is a Otc medication manufactured, distributed, or labeled by APR Beauty Group Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

Active Ingredient

Ethyl Alcohol, 70% w/w 

Purpose

Antiseptic

Uses

Kills harmful bacteria/germs

Warnings

 Flammable, keep away from open flame and sources of  heat.

For occasional and personal domestic use.

Stop use and consult a health care practitioner if irritation develops.

Avoid contact with eyes.

If contact occurs, rinse thoroughly with water.

If swallowed, call a posion control centre.

Directions

Rub thoroughly into hands for at least 30 seconds until dry.

For children 2 years and over supervise when product is used 

Other Information

Recommended storage conditions:

20 Degress Celsius

Inactive Ingredients

 Aloe barbadensis leaf juice, Aminomethyl Propanol, Glycerin , Propylene Glycol, Water, Isopropyl Myristate,Carbomer

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

SEALUXE HAND SANITIZER 
ethyl alcohol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 79959-001
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	70 mL  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)
WATER (UNII: 059QF0KO0R)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO)
GLYCERIN (UNII: PDC6A3C0OX)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
AMINOMETHYLPROPANOL (UNII: LU49E6626Q)
TOCOPHEROL (UNII: R0ZB2556P8)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 79959-001-24	240 mL in 1 BOTTLE; Type 0: Not a Combination Product	08/28/2020
2	NDC: 79959-001-50	500 mL in 1 BOTTLE; Type 0: Not a Combination Product	08/28/2020
3	NDC: 79959-001-35	315 mL in 1 BOTTLE; Type 0: Not a Combination Product	08/28/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	08/28/2020

Labeler - APR Beauty Group Inc. (204198006)