GOTHAN GRAPE SCENTED HAND SANITIZER 01- alochol gel 
Foshan Astar Industry 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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DU0001TA(EN) gothan grape/ blue
Foshan Astar

Active ingredient Purpose

Alcohol Denat. 70%(v/v)..... Antibacterial

Use

To decrease bacteria on the skin that could cause disease.

Warnings

For external use only.

Flammable. Keep away from fire or flame.

When using this product

  • Keep out of eyes.
  • Avoid contact with broken skin.

Stop use and ask a doctor if

  • Irritation or redness develops.

Keep out of reach of children

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

Direction

Rub a dime sized drop into hands.

For children under 8 use under adult supervision

Inactive ingredients

WATER(AQUA/EAU), PEG-40 HYDROGENATED CASTOR OIL, FRAGRANCE( PARFUM), ACRYLATES/ C10-30 ALKYL ACRYLATE CROSSPOLYMER, TRIETHANOLAMINE.
MAY CONTAIN: FD&C YELLOW NO. 5( CI19140), FD&C RED NO. 40( CI16035), FD&C BLUE NO.1(CI 42090), D&C RED NO. 33( CI 17200).

Questions?

1-212-779-0544 weekdays

77901-035-01

GOTHAN GRAPE SCENTED HAND SANITIZER  01
alochol gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:77901-035
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
TROLAMINE (UNII: 9O3K93S3TK) 0.16 g  in 100 mL
WATER (UNII: 059QF0KO0R) 36.2397 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 BLUE NO. 1 (UNII: H3R47K3TBD) 0.0003 g  in 100 mL
Product Characteristics
ColorblueScore    
ShapeSize
FlavorGRAPEImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:77901-035-0159 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 - Foshan Astar Industry Co., Ltd (421358695)
Registrant - Foshan Astar Industry Co., Ltd (421358695)
Establishment
NameAddressID/FEIBusiness Operations
Foshan Astar Industry Co., Ltd421358695manufacture(77901-035)

Revised: 4/2021
Document Id: bef7e7a0-f1b4-06cf-e053-2995a90a1ef6
Set id: bef7ea40-fd39-2d90-e053-2a95a90a8ebc
Version: 1
Effective Time: 20210402
 
Foshan Astar Industry Co., Ltd