Nicole Miller Hand Sanitizer

Nicole Miller Hand Sanitizer by

Drug Labeling and Warnings

Nicole Miller Hand Sanitizer by is a Otc medication manufactured, distributed, or labeled by Kobra International, Ltd., Ming Fai Innovative Skin Care Lab Limited. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

NICOLE MILLER HAND SANITIZER- alcohol gel 
Kobra International, 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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Nicole Miller Hand Sanitizer

DRUG FACTS

ACTIVE INGREDIENT

Ethyl Alcohol 75%

PURPOSE

Antiseptic

USES

to help reduce bacteria on the skin.

WARNINGS

For external use only. Use only as directed.

Flammable Keep away from fire or flame.

When using this product

Avoid contact with eyes or mouth In case of contact flush thoroughly with water.

Discontinue use

if irritation occurs. Consult doctor if irritation persists.

Keep out of reach of children

If swallowed get medical help or call a poison control center.

DIRECTIONS

Wet hands thoroughly with product and allow to dry without wiping. Children under 6,  use only under adult supervision.

OTHER INFORMATION

Store below 110°F (43°C).

INACTIVE INGREDIENTS

Water (Aqua), Glycerin, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Phenoxyethanol, Melaleuca Alternafolia (Tea Tree) Leaf Oil, Aminomethyl Propanol

Package Labeling:

BottleBox

NICOLE MILLER HAND SANITIZER 
alcohol gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 76551-015
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL0.75 mL  in 1 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
GLYCERIN (UNII: PDC6A3C0OX)  
CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
MELALEUCA ALTERNIFOLIA LEAF (UNII: G43C57162K)  
AMINOMETHYLPROPANOL (UNII: LU49E6626Q)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 76551-015-031 in 1 BOX07/15/202012/31/2022
150 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 finalpart333E07/15/202012/31/2022
Labeler - Kobra International, Ltd. (050349752)
Establishment
NameAddressID/FEIBusiness Operations
Ming Fai Innovative Skin Care Lab Limited663304471manufacture(76551-015)

Revised: 3/2023
Document Id: f7aae227-6a44-6546-e053-6294a90adda3
Set id: b146b1cb-e5fb-4836-9a84-5fbe3e92d199
Version: 3
Effective Time: 20230324