VANILLA CREAM- antibacterial gel hand wash liquid
Brands International

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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Vanilla Cream Antibacterial Gel Hand Wash

Drug Facts

Active Ingredients

Triclosan 0.115%

Purpose

Antibacterial

Uses

for handwashing to decrease bacteria on the skin

Warnings

For external use only.

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

When using this product do not get into eyes. If contact occurs, rinse eye thoroughly with water.

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Directions

wet hands
apply palmful to hands
scrub thoroughly
rinse

Inactive ingredients

Water, Sodium Laureth Sulfate, Sodium Chloride, DMDM Hydantoin, Citric Acid, Fragrance, EDTA, Yellow # 5, Red # 33

Package Label

Vanilla Cream Hand Wash

Antibacterial

Refill

14 oz / 414ml

Hand Soap

Label

VANILLA CREAM
antibacterial gel hand wash liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:50157-113
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
TRICLOSAN (UNII: 4NM5039Y5X) (TRICLOSAN - UNII:4NM5039Y5X)	TRICLOSAN	1.15 mg in 1 mL

Ingredient Name	Strength
Inactive Ingredients
WATER (UNII: 059QF0KO0R)
SODIUM LAURETH SULFATE (UNII: BPV390UAP0)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)
POLYQUATERNIUM-7 (70/30 ACRYLAMIDE/DADMAC; 1600 KD) (UNII: 0L414VCS5Y)
SODIUM LAUROAMPHOACETATE (UNII: SLK428451L)
D&C RED NO. 33 (UNII: 9DBA0SBB0L)
ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
METHYLCHLOROISOTHIAZOLINONE (UNII: DEL7T5QRPN)
METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)
GLYCOL DISTEARATE (UNII: 13W7MDN21W)
GLYCERIN (UNII: PDC6A3C0OX)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
ALOE VERA LEAF (UNII: ZY81Z83H0X)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:50157-113-14	414 mL in 1 BOTTLE; Type 2: Prefilled Drug Delivery Device/System (syringe, patch, etc.)	10/01/2015

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part333A	10/01/2015

Labeler - Brands International (243748238)

Name	Address	ID/FEI	Business Operations
Establishment
Brands International		243748238	manufacture(50157-113)