CREAMSICLE HAND SANITIZER- alcohol liquid 
ENCHANTE ACCESSORIES 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.

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Drug Fact

Active Ingredient

Ethyl Alcohol 62%

Purpose

Antiseptic

Uses

To decrease bacteria on the skin that could cause disease

Recommended for repeated use

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

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

Keep out of reach of children.

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

Directions

Other Information

Do not store above 105F

May discolor some fabrics

Harmful to wood finishes and plastics

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.

label

CREAMSICLE HAND SANITIZER 
alcohol liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50563-184
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL62 mL  in 100 mL
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:50563-184-0129 mL in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333E10/02/2014
Labeler - ENCHANTE ACCESSORIES INC. (186050696)
Registrant - Zhejiang Aidi Cosmetics Co., Ltd. (530876820)
Establishment
NameAddressID/FEIBusiness Operations
Zhejiang Aidi Cosmetics Co., Ltd.530876820manufacture(50563-184)

Revised: 10/2014
Document Id: 5029ed1a-b53f-4f5d-9973-3d987bb794ca
Set id: a71e5e47-5cf8-4bc3-b74f-10704d17a447
Version: 1
Effective Time: 20141002
 
ENCHANTE ACCESSORIES INC.