VANILLA CREAM- antibacterial gel hand wash liquid

Vanilla Cream by

Drug Labeling and Warnings

Vanilla Cream by is a Otc medication manufactured, distributed, or labeled by Brands International. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

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

WHEN USING

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

KEEP OUT OF REACH OF CHILDREN

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

INGREDIENTS AND APPEARANCE

VANILLA CREAM 
antibacterial gel hand wash liquid

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

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

Inactive Ingredients
Ingredient Name	Strength
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)

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

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

Labeler - Brands International (243748238)

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