Kandesn by Sunrider Manufacturing L.P. KANDESN- alcohol gel

Kandesn by

Drug Labeling and Warnings

Kandesn by is a Otc medication manufactured, distributed, or labeled by Sunrider Manufacturing L.P.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

Active Ingredient

Ethyl Alcohol 70%

Purpose

Antiseptic

Uses

• For handwashing to decrease bacteria on the skin
• Recommended for repeated use throughout the day

Warnings

For external use only

Flammable. Keep away from fire or flame.

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

Stop use and ask a doctor if irritation or rash appears and lasts

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Directions

• Place enough product in your palm to cover hands, rub hands together briskly until dry
• Children under 6 years of age should be supervised when using this product

Other information

Store below 110⁰F (43⁰C)

• May discolor certain fabrics or surfaces

Inactive ingredients

Water (Deionized), Salix Alba (Willow) Bark Extract, Ammonium Acryloyldimethyltaurate/VP Copolymer, Camellia Sinensis Leaf Extract, Menthol, Melaleuca Alternifolia (Tea Tree) Leaf Oil, Laurus Nobilis Leaf Extract, Rosmarinus Officinalis (Rosemary) Leaf Extract, PEG-40 Hydrogenated Castor Oil, Oleth-20, Fragrance

Questions or comments?

Call 1-310-781-8096

Principal Display Panel – 60 mL Bottle Label

KANDESN®

HAND
CLEANSING
GEL

70% Alcohol

SUNRIDER®

NET WT.

2 fl. oz. (60 mL)

INGREDIENTS AND APPEARANCE

KANDESN 
alcohol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 62191-085
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
Water (UNII: 059QF0KO0R)
Salix Alba Bark (UNII: 205MXS71H7)
Ammonium Acryloyldimethyltaurate/VP Copolymer (UNII: W59H9296ZG)
Green Tea leaf (UNII: W2ZU1RY8B0)
Menthol, Unspecified Form (UNII: L7T10EIP3A)
Tea Tree Oil (UNII: VIF565UC2G)
Bay Leaf (UNII: WS0Y3M85RF)
Rosemary (UNII: IJ67X351P9)
Polyoxyl 40 Hydrogenated Castor Oil (UNII: 7YC686GQ8F)
Oleth-20 (UNII: YTH167I2AG)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 62191-085-08	60 mL in 1 TUBE; Type 0: Not a Combination Product	04/22/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	04/22/2020

Labeler - Sunrider Manufacturing L.P. (786951475)

Establishment
Name	Address	ID/FEI	Business Operations
Sunrider Manufacturing L.P.		786951475	MANUFACTURE(62191-085)