CREAMSICLE HAND SANITIZER- alcohol liquid

Creamsicle Hand Sanitizer by

Drug Labeling and Warnings

Creamsicle Hand Sanitizer by is a Otc medication manufactured, distributed, or labeled by ENCHANTE ACCESSORIES INC. , Zhejiang Aidi Cosmetics Co., Ltd.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active Ingredient

Ethyl Alcohol 62%

PURPOSE

Purpose

Antiseptic

INDICATIONS & USAGE

Uses

To decrease bacteria on the skin that could cause disease

Recommended for repeated use

WARNINGS

For external use only-hands

Flammable. Keep away from heat and flame

Keep out of eyes. In case of comtact with eyes, flush thoroughly with water

Avoid contact with broken skin

ASK DOCTOR

Do not inhale or ingest. Stop use and ask a doctor if skin irritation develops

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children.

In case of accidental ingestion, seek professional assistance or contact a Poison Control Center immediately.

DOSAGE & ADMINISTRATION

Directions

• Wet hands thoroughly with product and allow to dry without wiping
• For children under 6, use only under adult supervision
• Not recommended for infants

SPL UNCLASSIFIED SECTION

Other Information

Do not store above 105F

May discolor some fabrics

Harmful to wood finishes and plastics

INACTIVE INGREDIENT

Inactive Ingredient:

Aqua, Carbomer, Triethanolamine, Parfum, Disodium EDTA, may contain D and C Red No. 33, FD and C Red No. 40, FD and C Blue No. 1, FD and C Yellow No. 5, FD and C Yellow No. 6.

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

CREAMSICLE HAND SANITIZER 
alcohol liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 50563-185
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)
EDETATE DISODIUM (UNII: 7FLD91C86K)
D&C RED NO. 33 (UNII: 9DBA0SBB0L)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)
FD&C RED NO. 40 (UNII: WZB9127XOA)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 50563-185-01	29 mL in 1 BOTTLE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333E	10/02/2014

Labeler - ENCHANTE ACCESSORIES INC. (186050696)

Registrant - Zhejiang Aidi Cosmetics Co., Ltd. (530876820)

Establishment
Name	Address	ID/FEI	Business Operations
Zhejiang Aidi Cosmetics Co., Ltd.		530876820	manufacture(50563-185)