HOLIDAY WONDERS FROSTED MARSHMALLOW ANTIBACTERIAL HAND SANITIZER- alcohol liquid

Holiday Wonders Frosted Marshmallow Antibacterial Hand Sanitizer by

Drug Labeling and Warnings

Holiday Wonders Frosted Marshmallow Antibacterial Hand Sanitizer by is a Otc medication manufactured, distributed, or labeled by ENCHANTE ACCESSORIES INC., Guangzhou St Eva Fine Chemical Co., Ltd.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active Ingredient

Ethyl Alcohol 62%

PURPOSE

Purpose

Antiseptic

INDICATIONS & USAGE

Uses

For hand washing to decrease bacteria on the skin

WARNINGS

For external use only-hands

Flammable. Keep away from heat and flame

Does not contain grain alcohol, do not drink. If taken internally will produce serious gastric disturbances

ASK DOCTOR

When using this product

Avoid the eyes and mucous membranes

In case of eye or mucous membrane contact, rinse area thoroughly with water

Stop use and ask a doctor if

Condiiton worsens

Redness or irritation develops

If condition persists for more than three days

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children.

If swallowed, contact a doctor or a Poison Control Center immediately.

DOSAGE & ADMINISTRATION

Directions

• Rub dime sized amount between hands until dry
• Supervise children in the use of this product
• In the case of eye contact, rinse eyes thoroughly with water

SPL UNCLASSIFIED SECTION

Other Information

Store below 105F

May discolor some fabrics

INACTIVE INGREDIENT

Inactive Ingredient:

Water, Glycerin, Propylene Glycol, FEG-40 Hydrogenated Castor Oil, Triethanolamine, Carbomer, tocopherol, Fragrance, D and C Red No. 33, FD and C Blue No. 1, FD and C Yellow No. 5,

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

HOLIDAY WONDERS FROSTED MARSHMALLOW ANTIBACTERIAL HAND SANITIZER 
alcohol liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 50563-191
Route of Administration	TOPICAL

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

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
CARBOMER COPOLYMER TYPE A (UNII: 71DD5V995L)
TROLAMINE (UNII: 9O3K93S3TK)
GLYCERIN (UNII: PDC6A3C0OX)
D&C RED NO. 33 (UNII: 9DBA0SBB0L)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
PEG-40 CASTOR OIL (UNII: 4ERD2076EF)
TOCOPHEROL (UNII: R0ZB2556P8)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 50563-191-01	40 mL in 1 BOTTLE; Type 0: Not a Combination Product	08/15/2016

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333E	08/15/2016

Labeler - ENCHANTE ACCESSORIES INC. (186050696)

Registrant - ENCHANTE ACCESSORIES INC. (186050696)

Establishment
Name	Address	ID/FEI	Business Operations
Guangzhou St Eva Fine Chemical Co., Ltd.		528039793	manufacture(50563-191)