E-PU PREMIUM MANDARIN HAND SANITIZING SERUM- ethyl alcohol lotion 
E.CIS Cosmetic Co.,Ltd

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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E-PU Premium Mandarin Hand Sanitizing Serum

Active Ingredient(s)

Alcohol 62% v/v. Purpose: Antiseptic

Active Ingredient(s)

Purpose

Antiseptic

Purpose

Use

Health care personnel hand rub to help reduce bacteria that potentially can cause disease.

Use

Warnings

For external use only. Flammable. Keep away from heat or flame

Warning

Do not use

Do not use

When using this product

When using this product keep out of eyes, ears, and mouth. In case of contact with eyes, rinse eyes thoroughly with water.

When using this product

Stop use and ask a doctor

Stop use and ask a doctor if irritation or rash occurs. These may be signs of a serious condition.

Stop use and ask a doctor

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.

Keep out of reach of children

Directions

Directions

Other information

Other Information

Inactive ingredients

Water, Cetyl Alcohol, Glycerin, Caprylic/Capric Triglyceride, Acrylates Copolymer, Fragrance, Carbomer, Aminomethyl Propanol, Styrene/Acrylates Copolymer, Olea Europaea (Olive) Fruit Oil, Panthenol, Aloe Barbadensis Leaf Extract, Tocopheryl Acetate, Macadamia Ternifolia Seed Oil, Butyrospermum Parkii (Shea) Butter, Argania Spinosa Kernel Oil, Sodium Hyaluronate

Inactive ingredients

Package Label - Principal Display Panel


E-PU
2 in 1
Premium Mandarin
Hand Sanitizing Serum
62% Ethyl Alcohol as recommended
2 in 1 Hand Sanitizer & Moisturizing Hand Serum
E-PU Premium 2 in 1 Hand Sanitizing Serum is
formulated with Natural Fragrance, Mandarin
Zest and Herbal Oils, complying with ISO 9235.
Helps reduce bacteria, while leaving your hand
feeling refreshed, soft and clean. Enriched with
Olive Fruit Oil, Sodium Hyaluronate & Aloe Vera
which help to leave your hands fully moisturized
and hydrated even after sanitizing.
100ml / 3.38 fl.oz.

Package Label - Principal Display Panel

E-PU PREMIUM MANDARIN HAND SANITIZING SERUM 
ethyl alcohol lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:73862-218
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL62 mL  in 100 mL
Inactive Ingredients
Ingredient NameStrength
BUTYL ACRYLATE/METHYL METHACRYLATE/METHACRYLIC ACID COPOLYMER (18000 MW) (UNII: JZ1374NL9E)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
ARGAN OIL (UNII: 4V59G5UW9X)  
HYALURONATE SODIUM (UNII: YSE9PPT4TH)  
ACRYLIC ACID (UNII: J94PBK7X8S)  
GLYCERIN (UNII: PDC6A3C0OX)  
CETYL ALCOHOL (UNII: 936JST6JCN)  
WATER (UNII: 059QF0KO0R)  
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
CARBOMER 940 (UNII: 4Q93RCW27E)  
MACADAMIA OIL (UNII: 515610SU8C)  
AMINOMETHYLPROPANOL (UNII: LU49E6626Q)  
OLIVE OIL (UNII: 6UYK2W1W1E)  
PANTHENOL (UNII: WV9CM0O67Z)  
SHEA BUTTER (UNII: K49155WL9Y)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:73862-218-1260 in 1 CARTON07/31/2020
1NDC:73862-218-116 in 1 CASE
1NDC:73862-218-10100 mL in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A07/31/2020
Labeler - E.CIS Cosmetic Co.,Ltd (689846270)
Registrant - E.CIS Cosmetic Co.,Ltd (689846270)
Establishment
NameAddressID/FEIBusiness Operations
E.CIS Cosmetic Co.,Ltd689846270manufacture(73862-218)

Revised: 6/2020
Document Id: a8d01bd6-8817-35c7-e053-2a95a90a6cb4
Set id: a8cfd2c2-3f99-b0d4-e053-2995a90ae51b
Version: 1
Effective Time: 20200624
 
E.CIS Cosmetic Co.,Ltd