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Name:Anti-bacterial Hand
Manufacturer:Jets, Sets, & Elephants Beauty Corp.
Category:Over-the-counter (OTC) Marketed Drugs


bath-body-etc® anti-bacterial hand gel - Sweet Cherry Blossom and Warm Vanilla Sugar

ANTI-BACTERIAL HAND - alcohol gel 
Jets, Sets, & Elephants Beauty Corp.

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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bath-body-etc® anti-bacterial hand gel - Sweet Cherry Blossom and Warm Vanilla Sugar

ACTIVE INGREDIENT

Ethyl Alcohol 62% w/w

PURPOSE

Anti-bacterial

USE

  • To decrease bacteria on the skin and clean hands.
  • Recommended for repeated use.

WARNINGS

For external use only. Flammable, keep away from fire or flame.

Keep out of reach of children.

If accidentally swallowed, get medical help or contact a Poison Control Center right away.

Do not get into eyes.

If contact occurs, rinse thoroughly with water.

Discontinue use

if irritation or redness develop. If irritation persists for more than 72 hours, consult a doctor.

DIRECTIONS

  • Apply to hands until thoroughly wet.
  • Rub vigorously until dry.
  • Supervise children in the use of this product.

Inactive Ingredients

Sweet Cherry Blossom

Water, Propylene Glycol, Parfum, Aloe Barbadensis, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Polysorbate 20, Triethanolamine, Lactose, Cellulose, Hydroxypropyl Methylcellulose, Tocopheryl Acetate, Iron Oxide, Retinyl Palmitate, Red 33, Yellow 5

Warm Vanilla Sugar

Water, Propylene Glycol, Parfum, Aloe Barbadensis, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Polysorbate 20, Triethanolamine, Lactose, Cellulose, Hydroxypropyl Methylcellulose, Tocopheryl Acetate, Iron Oxide, Retinyl Palmitate, Red 33, Yellow 5, Blue 1

QUESTIONS?

1-800-FDA-1088

Made in China

Distributed by Jets, Sets & Elephants Beauty Corp.

For ShopKo Stores Operating Co., LLC

Green Bay, WI 54307, U.S.A

©2010 ShopKo Stores Operating Co., LLC

PACKAGE/LABEL PRINCIPAL DISPLAY PANEL - BOTTLE LABEL

bath-body-etc®

Sweet Cherry Blossom

anti-bacterial

hand gel

PARABEN FREE

contains aloe vera and

vitamins A & E

1 fl oz

Bottle Label

Sweet Cherry Blossom Bottle Label

PACKAGE/LABEL PRINCIPAL DISPLAY PANEL - BOTTLE LABEL

bath-body-etc®

Warm Vanilla Sugar

anti-bacterial

hand gel

PARABEN FREE

contains aloe vera and

vitamins A & E

1 fl oz

Bottle Label

Warm Vanilla Sugar Bottle Label


ANTI-BACTERIAL HAND 
ethyl alcohol gel
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:50988-270
Route of Administration TOPICAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ALCOHOL (ALCOHOL) ALCOHOL 18.335 mL  in 29.574 mL
Inactive Ingredients
Ingredient Name Strength
WATER  
PROPYLENE GLYCOL  
ALOE VERA LEAF  
CARBOMER INTERPOLYMER TYPE A (55000 MPA.S))  
POLYSORBATE 20  
TROLAMINE  
LACTOSE  
.ALPHA.-TOCOPHEROL ACETATE, D-  
FERRIC OXIDE RED  
VITAMIN A PALMITATE  
D&C RED NO. 33  
FD&C YELLOW NO. 5  
FD&C BLUE NO. 1  
Product Characteristics
Color      Score     
Shape Size
Flavor Imprint Code
Contains     
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:50988-270-00 4 CARTON ( CARTON) in 1 BOX contains a CARTON
1 12 BOTTLE, PLASTIC ( BOTTLE) in 1 CARTON This package is contained within the BOX (50988-270-00) and contains a BOTTLE, PLASTIC
1 29.574 mL in 1 BOTTLE, PLASTIC This package is contained within a CARTON and a BOX (50988-270-00)
2 NDC:50988-270-01 4 CARTON ( CARTON) in 1 BOX contains a CARTON
2 12 BOTTLE, PLASTIC ( BOTTLE) in 1 CARTON This package is contained within the BOX (50988-270-01) and contains a BOTTLE, PLASTIC
2 29.574 mL in 1 BOTTLE, PLASTIC This package is contained within a CARTON and a BOX (50988-270-01)

Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph final part333A 04/11/2011

Labeler - Jets, Sets, & Elephants Beauty Corp. (243254039)
Establishment
Name Address ID/FEI Operations
Gold Orient International Limited 679905914 MANUFACTURE

Revised: 03/2011 Jets, Sets, & Elephants Beauty Corp.



Source: http://dailymed.nlm.nih.gov
Reproduced with permission of U.S. National Library of Medicine


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