BeCause Antibacterial Hand Gel

Drug Details [pdf]

BECAUSE ANTIBACTERIAL HAND JAFRA- ethyl alcohol gel
Jafra Cosmetics International Inc

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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BeCause Antibacterial Hand Gel

Active Ingredients Purpose

Ethyl Alcohol 62% Antimicrobial

Uses

To help reduce bacteria on the skin

Keep out of reach of children. If swallowed, get medical help or cotact a poison control Center right away.

Stop use and ask a doctor if irritation or redness develops and lasts

Warnings

For external use only

Avoid contact with eyes. If contact occurs, rinse thouroughly with water.

Directions

Place enough product in your palm to thoroughly cover your hands

Rub hands together briskly until dry

Children under 6 years of age should be supervised when using this product

Inactive ingredients

Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Aloe Barbadensis Leaf Juice, Aminomethyl Propanol, Butylene Glycol, Cellulose, Chromium Hydroxide Green, Fragrance/Parfum, Glycerin, Hydroxypropyl Methylcellulose, Isopropyl Myristate, Mannitol, Tocopheryl Acetate, Water/Aqua

Carton label

BECAUSE ANTIBACTERIAL HAND JAFRA
ethyl alcohol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 68828-174
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	62 g in 100 mL

Ingredient Name	Strength
Inactive Ingredients
CARBOMER COPOLYMER TYPE A (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 71DD5V995L)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
AMINOMETHYLPROPANOL (UNII: LU49E6626Q)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
POWDERED CELLULOSE (UNII: SMD1X3XO9M)
CHROMIUM HYDROXIDE GREEN (UNII: RV8FT8XF5R)
GLYCERIN (UNII: PDC6A3C0OX)
HYPROMELLOSE 2910 (5 MPA.S) (UNII: R75537T0T4)
ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)
MANNITOL (UNII: 3OWL53L36A)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
WATER (UNII: 059QF0KO0R)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC: 68828-174-02	1 in 1 CARTON	07/30/2013	09/26/2018
1	NDC: 68828-174-01	60 mL in 1 BOTTLE; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part333E	07/30/2013	09/26/2018

Labeler - Jafra Cosmetics International Inc (041676479)

Registrant - Jafra Cosmetics International Inc (041676479)

Name	Address	ID/FEI	Business Operations
Establishment
Jafra Manufacturing, S.A. de C.V.		814732061	manufacture(68828-174)

Revised: 5/2019

Document Id: 4515b6e1-40f1-431f-a01f-e41cb2e3edbc

Set id: 2a207b2e-eb02-49c5-85e4-814cd14d8296

Version: 6

Effective Time: 20190521

BeCause Antibacterial Hand Gel

Drug Labeling and Warnings

Drug Details [pdf]

BeCause Antibacterial Hand Gel