HAND SANITIZER- alcohol gel 
Fujian Shuangfei Daily Chemicals 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.

----------

HAND SANITIZER - 70% V/V ALCOHOL DENAT

ACTIVE INGREDIENT

ALCOHOL DENAT. 70% V/V

PURPOSE

ANTISEPTIC

USES

HAND SANITIZER TO HELP REDUCE BACTERIA ON THE SKIN

WARNINGS

Flammable. Keep away from fire or flame. For external use only. Do not ingest, if swallowed seek medical help. Avoid contact with eyes.

Keep out of reach of children.

Children under 6 years old to use under adult supervision. in case of irritation, discontinue use and consult your doctor.

DIRECTIONS

Apply the gel on the hands and rub gently for 20 seconds until the product evaporates. allow to dry without wiping. Not recommended for infants.

OTHER INFORMATION

Store below 106°F (41°C). May discolor certain fabrics or surfaces.

INACTIVE INGREDIENTS

Alcohol denat., Water/Aqua, Acrylates/C10-30 Alkyl Crosspolymer, Aminomethyl propanol, Fragrance/Parfum, Glycerin, Citral*, Linalool*, Butylene glycol, Alor barbadensis leaf extract.  *Naturally found in essential oils

01b LBL_Medex Hand Sanitizer_50mL

HAND SANITIZER 
alcohol gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:76854-102
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)  
CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO)  
AMINOMETHYLPROPANOL (UNII: LU49E6626Q)  
GLYCERIN (UNII: PDC6A3C0OX)  
CITRAL (UNII: T7EU0O9VPP)  
LINALOOL, (+)- (UNII: F4VNO44C09)  
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:76854-102-1150 mL in 1 TUBE; Type 0: Not a Combination Product06/22/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A06/22/2020
Labeler - Fujian Shuangfei Daily Chemicals Co.,Ltd. (527296914)

Revised: 6/2020
Document Id: fdbc98dc-54e8-429c-b5dd-b6f476b12965
Set id: e585649f-e022-4680-b966-69c4074d0838
Version: 1
Effective Time: 20200623
 
Fujian Shuangfei Daily Chemicals Co.,Ltd.