NAKED NATURALS HAND SANITIZER WITH VITAMIN E- alcohol gel 
Welburn Corporation

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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Hand Sanitizer with Vitamin E - Welburn Corporation

Drug Facts

Active ingredients

Alcohol 70% v/v

Purpose

Antiseptic

Uses

Hand Sanitizer to help reduce bacteria that can potentially cause disease. For use when soap and water are not available.

Warnings

For external use only.

Flammable. Keep away from heat or flame.

Do not use

  • On children less than 2 months of age.
  • On open skin wounds.

When using this product

Keep out of eyes, ears and mouth. In case of contact with eyes rinse thoroughly with water.

Stop use and seek a doctor

If irritation or rash occurs. These may be signs of a serious condition.

Keep out of reach of children.

If ingested, get medical help or contact a Poison Control Center right away.

Directions

Place enough product on hands to cover all surfaces. Rub hands together until dry.

Supervise children under 6 years of age when using this product to avoid ingestion.

Other information

Inactive ingredients

Water, Carbomer, Glycerin, Triethanolamine, Iodopropynyl Butylcarbamate, Methylisothiazolinone, Tocopheryl Acetate, Blue 1 (CI 42090).

Questions?

call 888 387 3887

Company Information

Dist: Welburn Corporation

PO BOX 1392

Hermosa Beach, CA 90254

Made in Guatemala

Product Packaging - 500ml

ADVANCED FORMULA!

NAKED

NATURALS

HAND SANITIZER

WITH VITAMIN E

NON STERILE SOLUTION

ALCOHOL 70%

16.9 fl. oz. / 500ml

vitamin e sanitizer

NAKED NATURALS HAND SANITIZER WITH VITAMIN E 
alcohol gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:77622-007
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
GLYCERIN (UNII: PDC6A3C0OX)  
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)  
METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)  
IODOPROPYNYL BUTYLCARBAMATE (UNII: 603P14DHEB)  
TROLAMINE (UNII: 9O3K93S3TK)  
WATER (UNII: 059QF0KO0R)  
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:77622-007-0159 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product06/25/2020
2NDC:77622-007-02118 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product06/25/2020
3NDC:77622-007-04236 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product06/25/2020
4NDC:77622-007-03280 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product06/25/2020
5NDC:77622-007-05458 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product06/25/2020
6NDC:77622-007-061000 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product06/25/2020
7NDC:77622-007-072000 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product06/25/2020
8NDC:77622-007-083785 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product06/25/2020
9NDC:77622-007-091000000 mL in 1 CONTAINER; Type 0: Not a Combination Product06/25/2020
10NDC:77622-007-10500 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product06/25/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A06/25/2020
Labeler - Welburn Corporation (117515830)

Revised: 6/2020
Document Id: a8fdcf74-e00b-483b-e053-2a95a90a8665
Set id: a8fddcbd-84f9-1230-e053-2995a90aeede
Version: 1
Effective Time: 20200625
 
Welburn Corporation