HAND SANITIZER  - hand sanitizer  gel 
Fercy Personal Care Products Co Limited

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

Hand sanitizer to reduce bacteria on the skin that potentially can cause disease

Warning

Flamable, keep away from children or flame.

For external use only.
                                             
Do not use in the eyes.In case of accidental contact with eyes,

flush eyes with water. Consult a doctor.
                                               
Discontinue use if irritation or redness develop.If condition

persists for more than 72 hours,consult a doctor.
                                              
Keep out of reach of children.If swallowed, get medical help

or contact a Poison Control Center right away.

Directions

Wet hands thoroughly with product and rub hands together until dry. No need to wash or rinse your hands

or use towels.

Supervise children under 6 years of age.

Other Information

·Do not store above 110 oF(43 oC).

·May discolor some fabrics, or may ham some wood finishes

and plastics.


Deionized water,Glycerin,Propylene Glycol,Triethanolamine,Carbomer,Methylparaben,Propylparaben,Fragrance.


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phot of druglisting

HAND SANITIZER  
hand sanitizer gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50260-200
Route of AdministrationPERCUTANEOUS
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL 62 mL  in 100 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R) 31.1 mL  in 100 mL
GLYCERIN (UNII: PDC6A3C0OX) 2 mL  in 100 mL
PROPYLENE GLYCOL (UNII: 6DC9Q167V3) 2 mL  in 100 mL
TROLAMINE (UNII: 9O3K93S3TK) 1 mL  in 100 mL
CARBOMER 934 (UNII: Z135WT9208) 0.9 mL  in 100 mL
Methylparaben (UNII: A2I8C7HI9T) 0.5 mL  in 100 mL
Propylparaben (UNII: Z8IX2SC1OH) 0.5 mL  in 100 mL
Product Characteristics
Colorblue, green, red, pink, yellowScore    
ShapeSize
FlavorAPPLE, BANANA, BERRY, GRAPE, CHERRY, MANGO, LEMON, BLUEBERRY, PEACH, STRAWBERRY, ORANGE, WATERMELONImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:50260-200-015 mL in 1 BOTTLE, PLASTIC
2NDC:50260-200-028 mL in 1 BOTTLE, PLASTIC
3NDC:50260-200-0310 mL in 1 BOTTLE, PLASTIC
4NDC:50260-200-0420 mL in 1 BOTTLE, PLASTIC
5NDC:50260-200-0530 mL in 1 BOTTLE, PLASTIC
6NDC:50260-200-0650 mL in 1 BOTTLE, PLASTIC
7NDC:50260-200-0760 mL in 1 BOTTLE, PLASTIC
8NDC:50260-200-08100 mL in 1 BOTTLE, PLASTIC
9NDC:50260-200-09120 mL in 1 BOTTLE, PLASTIC
10NDC:50260-200-10240 mL in 1 BOTTLE, PLASTIC
11NDC:50260-200-11360 mL in 1 BOTTLE, PLASTIC
12NDC:50260-200-12500 mL in 1 BOTTLE, PLASTIC
13NDC:50260-200-131000 mL in 1 BOTTLE, PLASTIC
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34802/01/2010
Labeler - Fercy Personal Care Products Co Limited (529623870)
Establishment
NameAddressID/FEIBusiness Operations
Fercy Personal Care Products Co Limited529623870manufacture

Revised: 2/2010
Document Id: 4a6a41af-8bad-4153-a8c0-b410f1455fad
Set id: bb74eac4-526d-4979-a0e6-6281b8c111a6
Version: 1
Effective Time: 20100201
 
Fercy Personal Care Products Co Limited