GRAPE SCENTED HAND SANITIZER 01- alochol gel 
Jiangxi Iris Chemical Co., ltd

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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TD0567TB(EN)/ TD0567TB(EN/FR/SP),purple, grape
Jiangxi Iris Chemical Co., ltd

Drug facts

Active ingredient .............purpose

alcohol Denate: 70%(v/v)..... Antibacterial

Use

To decrease bacteria on the skin that could cause disease.

Warnings

For external use only-hands

keep out of eyes- avoid contact with broken skin.

Keep away from fire.

Stop use and ask a dosctor if irritation or radness develops

Do not inhale or ingest. If swallowed, get medical help or contact a poison control right away.

Direction

Rub a dime sized drop into hands.

For children under 8 use under adult supervision

Inactive ingredients

INACTIVE INGREDIENTS: WATER(AQUA/EAU), PEG-40 HYDROGENATED CASTOR OIL, FRAGRANCE( PARFUM), ACRYLATES/ c10-30 ALKYL ACRYLATE CROSSPOLYMER, TRIETHANOLAMINE.
MAY CONTAIN: FD&C RED 40, D&C RED 33, FD&C BLUE 1, FD&C YELLOW 5.

Questions?

1-212-779-0544 weekdays

74440-028-0174440-028-02

GRAPE SCENTED HAND SANITIZER  01
alochol gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:74440-028
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL70 mL  in 100 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R) 36.2397 g  in 100 mL
FD&C BLUE NO. 1 (UNII: H3R47K3TBD) 0.0003 g  in 100 mL
TROLAMINE (UNII: 9O3K93S3TK) 0.16 g  in 100 mL
GRAPE (UNII: 6X543N684K) 0.2 g  in 100 mL
CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO) 0.2 mL  in 100 mL
POLYOXYL 40 HYDROGENATED CASTOR OIL (UNII: 7YC686GQ8F) 0.2 mL  in 100 mL
FD&C RED NO. 40 (UNII: WZB9127XOA) 0.0003 g  in 100 mL
Product Characteristics
ColorpurpleScore    
ShapeSize
FlavorGRAPEImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:74440-028-0159 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product06/19/2020
2NDC:74440-028-0259 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product06/19/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A06/19/2020
Labeler - Jiangxi Iris Chemical Co., ltd (544366795)
Registrant - Jiangxi Iris Chemical Co., ltd (544366795)
Establishment
NameAddressID/FEIBusiness Operations
Jiangxi Iris Chemical Co., ltd544366795manufacture(74440-028)

Revised: 7/2020
Document Id: aac0f623-8503-6f96-e053-2a95a90a54b8
Set id: aac0f623-8504-6f96-e053-2a95a90a54b8
Version: 1
Effective Time: 20200718
 
Jiangxi Iris Chemical Co., ltd