KANDESN- alcohol gel 
Sunrider Manufacturing L.P.

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 Ingredient

Ethyl Alcohol 70%

Purpose

Antiseptic

Uses

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

Other information

Store below 110⁰F (43⁰C)

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)

Principal Display Panel – 60 mL Bottle Label
KANDESN 
alcohol gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:62191-085
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Alcohol (UNII: 3K9958V90M) (Alcohol - UNII:3K9958V90M) Alcohol70 mL  in 100 mL
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:62191-085-0860 mL in 1 TUBE; Type 0: Not a Combination Product04/22/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A04/22/2020
Labeler - Sunrider Manufacturing L.P. (786951475)
Establishment
NameAddressID/FEIBusiness Operations
Sunrider Manufacturing L.P.786951475MANUFACTURE(62191-085)

Revised: 4/2020
Document Id: 05ba4794-5ff6-4b31-b0d2-8a996e877be4
Set id: 0ddc7596-ef92-4ec8-82f3-57651dbdfd7c
Version: 1
Effective Time: 20200422
 
Sunrider Manufacturing L.P.