WELLNICITY HAND SANITIZER- alcohol gel

Wellnicity Hand Sanitizer by

Drug Labeling and Warnings

Wellnicity Hand Sanitizer by is a Otc medication manufactured, distributed, or labeled by United Laboratories Manufacturing, LLC, Dibar Nutricional, S. de R.L. de C.V.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredients

Ethyl Alcohol 70.0% v/v

Purpose

Anti Microbial

Warnings

Flammable: keep away from excessive heat or open flame.

For external use only.

Do not use 

in or near eyes. In case of eye contact, flush with water. Do not apple to open wounds or damaged skin.  

Keep out of reach of children.

Stop use and consult a doctor

if irritation occurs.

Directions

• Aplly entire packet to palm of hand. Use no water or towels. Rub until hands are completely covered.

Inactive ingredients

Distilled Water, Biopol Plus / Carbomer 940, Aloe Vera Aqueous Extract, Aminomethyl Propane, Rapidgel.

Uses

• Hand sanitizer helps reduce bacteria on the skin could cause disease.

Product Label

C:\Users\RegCorp 142\Downloads\Download SPL\Listings to submit to FDA\United Laboratories Manufacturing, LLC (73009-017) Wellnicity Hand Sanitizer

INGREDIENTS AND APPEARANCE

WELLNICITY HAND SANITIZER 
alcohol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 62400-0017
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	0.7 mL  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 4Q93RCW27E)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
AMINOMETHYL PROPANEDIOL (UNII: CZ7BU4QZJZ)
RAPIDGEL EZ1 (UNII: 33JH4A7R2K)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 62400-0017-1	1000 in 1 BOX	07/30/2020
1		2.25 mL in 1 PACKAGE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333E	07/30/2020

Labeler - United Laboratories Manufacturing, LLC (807878116)

Establishment
Name	Address	ID/FEI	Business Operations
Dibar Nutricional, S. de R.L. de C.V.		812786543	manufacture(62400-0017) , label(62400-0017) , pack(62400-0017)