K-Hand Sanitizer by UI COSMETICS CO., LTD 0030

K-Hand Sanitizer by

Drug Labeling and Warnings

K-Hand Sanitizer by is a Otc medication manufactured, distributed, or labeled by UI COSMETICS CO., LTD. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

K-HAND SANITIZER- alcohol gel 
UI COSMETICS 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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0030

ACTIVE INGREDIENT

Isopropyl Alcohol 75%

PURPOSE

Antiseptic

USES

To help reduce bacteria on the skin

WARNINGS

For external use only.

Flammable, keep away from heat or flames.

WHEN USING THIS PRODUCT

keep away from eyes. In case of eye contact, rinse eyes with water.

STOP USE AND ASK DOCTOR IF

irritation and redness develop and persist.

KEEP OUT OF REACH OF CHILDREN.

DIRECTIONS

Apply a small amount in your palm and rub hands together briskly until dry.

Supervise children under 6 years in the use of product.

OTHER INFORMATION

Protect this product from excessive heat and direct sun.

INACTIVE INGREDIENTS

Water, Carbomer, Triethanolamine, Glycerin, Aloe Vera, Tocopheryl Acetate

PACKAGE LABEL

60ml NDC: <a href=/NDC/75615-0030-0>75615-0030-0</a> Label

100ml NDC: <a href=/NDC/75615-0030-1>75615-0030-1</a> Label

250ml NDC: <a href=/NDC/75615-0030-2>75615-0030-2</a> Label

300ml NDC: <a href=/NDC/75615-0030-3>75615-0030-3</a> Label

500ml NDC: <a href=/NDC/75615-0030-4>75615-0030-4</a> Label

1000ml NDC: <a href=/NDC/75615-0030-5>75615-0030-5</a> Label

3785ml NDC: <a href=/NDC/75615-0030-6>75615-0030-6</a> Label

5000ml NDC: <a href=/NDC/75615-0030-7>75615-0030-7</a> Label

10000ml NDC: <a href=/NDC/75615-0030-8>75615-0030-8</a> Label

18750ml NDC: <a href=/NDC/75615-0030-9>75615-0030-9</a> Label

K-HAND SANITIZER 
alcohol gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 75615-0030
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ISOPROPYL ALCOHOL (UNII: ND2M416302) (ISOPROPYL ALCOHOL - UNII:ND2M416302) ISOPROPYL ALCOHOL75 mL  in 100 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
TROLAMINE (UNII: 9O3K93S3TK)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)  
GLYCERIN (UNII: PDC6A3C0OX)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 75615-0030-060 mL in 1 BOTTLE; Type 0: Not a Combination Product07/28/2020
2NDC: 75615-0030-1100 mL in 1 BOTTLE; Type 0: Not a Combination Product07/28/2020
3NDC: 75615-0030-2250 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product07/28/2020
4NDC: 75615-0030-3300 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product07/28/2020
5NDC: 75615-0030-4500 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product07/28/2020
6NDC: 75615-0030-51000 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product07/28/2020
7NDC: 75615-0030-63785 mL in 1 BOTTLE; Type 0: Not a Combination Product07/28/2020
8NDC: 75615-0030-75000 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product07/28/2020
9NDC: 75615-0030-810000 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product07/28/2020
10NDC: 75615-0030-918750 mL in 1 BOTTLE; Type 0: Not a Combination Product07/28/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A07/28/202012/30/2020
Labeler - UI COSMETICS CO., LTD (688362189)
Registrant - UI COSMETICS CO., LTD (688362189)
Establishment
NameAddressID/FEIBusiness Operations
UI COSMETICS CO., LTD688362189manufacture(75615-0030)

Revised: 12/2020
Document Id: b7a92b17-ae1f-7d29-e053-2995a90a402c
Set id: ab7c711f-8f28-be06-e053-2995a90a6484
Version: 2
Effective Time: 20201230
 
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