BECAUSE ANTIBACTERIAL HAND JAFRA- triclosan cream
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.

----------

BeCause Antibacterial Hand Cream

Active ingredients Purpose

Triclosan 0.3% Antimicrobial

Uses

To help reduce bacteria on the skin

Keep out of reach of children

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 thoroughly with water.

Directions

Apply a small amount to palm and rub hands together throrughly.

Inactive ingredients

Allantoin, Aloe Barbadensis Leaf Juice, Beeswax/Cera Alba, Butylene Glycol, Butyrospermum Parkii (Shea Butter) Fruit, Carbomer, Cetyl Alcohol, Diazolidinyl Urea, Dimethicone, Disodium EDTA, DMDM Hydantoin, Fragrance/parfum, Glyceryl Stearate SE, Glyceryl Stearate, Hydroxypropyl Methylcellulose, Mannitol Cellulose, Octyl Palmitate, PEG-100 Stearate, Retinyl Palmitate, Sorbitol, Stearic Acid, Tocopheryl, Tocopheryl Acetate, Tricaprylin, Triethanolamine, Ultramarines, Water/Aqua, Xanthan Gum

Carton

Jafra BeCause

Antibacterial Hand Cream

Crema Antibacterial Para Manos
75 ml 2.5 FL OZ (US)

BECAUSE ANTIBACTERIAL HAND JAFRA
triclosan cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:68828-175
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
TRICLOSAN (UNII: 4NM5039Y5X) (TRICLOSAN - UNII:4NM5039Y5X)	TRICLOSAN	0.3 g in 100 mL

Ingredient Name	Strength
Inactive Ingredients
ALLANTOIN (UNII: 344S277G0Z)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
YELLOW WAX (UNII: 2ZA36H0S2V)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
SHEA BUTTER (UNII: K49155WL9Y)
CARBOMER 940 (UNII: 4Q93RCW27E)
CETYL ALCOHOL (UNII: 936JST6JCN)
DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4)
DIMETHICONE (UNII: 92RU3N3Y1O)
EDETATE DISODIUM (UNII: 7FLD91C86K)
DMDM HYDANTOIN (UNII: BYR0546TOW)
GLYCERYL STEARATE SE (UNII: FCZ5MH785I)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
HYPROMELLOSE 2910 (5 MPA.S) (UNII: R75537T0T4)
ETHYLHEXYL PALMITATE (UNII: 2865993309)
PEG-100 STEARATE (UNII: YD01N1999R)
VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)
SORBITOL (UNII: 506T60A25R)
STEARIC ACID (UNII: 4ELV7Z65AP)
TOCOPHEROL (UNII: R0ZB2556P8)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
TRICAPRYLIN (UNII: 6P92858988)
TROLAMINE (UNII: 9O3K93S3TK)
WATER (UNII: 059QF0KO0R)
ULTRAMARINE BLUE (UNII: I39WR998BI)
XANTHAN GUM (UNII: TTV12P4NEE)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:68828-175-02	1 in 1 CARTON	07/31/2013	09/26/2018
1	NDC:68828-175-01	75 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	part333A	07/31/2013	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(68828-175)

Revised: 5/2019

Document Id: 0ee46b1e-cdb3-4475-aa08-fe70959698d9

Set id: 6a430b60-1383-43a1-91ef-a2498f17509d

Version: 5

Effective Time: 20190521

Jafra Cosmetics International Inc