NDC | 29500-9413-1, 29500-9414-1, 29500-9415-1, 29500-9416-1 |
Set ID | bdea9a5e-bcec-43ee-9de4-658d100b4a7e |
Category | HUMAN OTC DRUG LABEL |
Packager | GL 360 |
Generic Name | |
Product Class | |
Product Number | |
Application Number | PART333E |
- SPL UNCLASSIFIED SECTION
- Active Ingredients
- Purpose
- INDICATIONS & USAGE
- Warning
- WHEN USING
- STOP USE
- KEEP OUT OF REACH OF CHILDREN
- DOSAGE & ADMINISTRATION
- INACTIVE INGREDIENT
-
Product Labels for:
Burger Time
Fresh Fries
Pizza Party
Sparkled Donut
Burger Time Hand Sanitizer Label
Burger Time
HAND SANITIZER
Drug Facts
Active
Ingredients
Ethyl Alcohol 62.0%Purpose
AntimicrobialUse hand sanitizer
to help reduce
bacteria on skin.ADDITIONAL DRUG FACTS
Distributed By:
Personal Care Products, LLC
Troy, Michigan 48084
Made in ChinaDrug Facts
(continued)Flammable Keep
away from heat and
flameWhen using this
product avoid contact
with eyes. If contact
occurs, rinse
thoroughly with water.Stop use and ask
doctor if irritation or
redness developsKeep out of reach
of children.
If swallowed, get
medical help or
contact a Poison
Control Center
right away.Drug Facts
(continued)Directions
■ Wet hands
thoroughly with
product and rub
into skin until dry.
■ Children under
6 years of age
should be
supervised by an
adult when using.Inactive
Ingredients
Water (Aqua), Aloe
Barbadensis Leaf Juice,
Carbomer, Fragrance,
Glycerin, Propylene
Glycol, Triethanolamine,
Tocopheryl Acetate
FD&C Yellow No. 5,
FD&C Blue No. 1Fresh Fries Hand Sanitizer Label
Pizza Party Hand Sanitizer Label
Sparkled Donut Hand Sanitizer Label -
INGREDIENTS AND APPEARANCE
BURGER TIME HAND SANITIZER
alcohol liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:29500-9413 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL 17.57 g in 30 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) ALOE VERA LEAF (UNII: ZY81Z83H0X) CARBOXYPOLYMETHYLENE (UNII: 0A5MM307FC) GLYCERIN (UNII: PDC6A3C0OX) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) TROLAMINE (UNII: 9O3K93S3TK) .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) FD&C YELLOW NO. 5 (UNII: I753WB2F1M) FD&C BLUE NO. 1 (UNII: H3R47K3TBD) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:29500-9413-1 30 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 03/01/2018 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part333E 03/01/2018 FRESH FRIES HAND SANITIZER
alcohol liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:29500-9414 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL 17.57 g in 30 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) ALOE VERA LEAF (UNII: ZY81Z83H0X) CARBOXYPOLYMETHYLENE (UNII: 0A5MM307FC) GLYCERIN (UNII: PDC6A3C0OX) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) TROLAMINE (UNII: 9O3K93S3TK) .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) FD&C BLUE NO. 1 (UNII: H3R47K3TBD) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:29500-9414-1 30 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 03/01/2018 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part333E 03/01/2018 PIZZA PARTY HAND SANITIZER
alcohol liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:29500-9415 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL 17.57 g in 30 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) ALOE VERA LEAF (UNII: ZY81Z83H0X) CARBOXYPOLYMETHYLENE (UNII: 0A5MM307FC) GLYCERIN (UNII: PDC6A3C0OX) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) TROLAMINE (UNII: 9O3K93S3TK) .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) FD&C YELLOW NO. 5 (UNII: I753WB2F1M) FD&C RED NO. 40 (UNII: WZB9127XOA) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:29500-9415-1 30 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 03/01/2018 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part333E 03/01/2018 SPARKLED DONUT HAND SANITIZER
alcohol 62% liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:29500-9416 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL 17.57 g in 30 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) ALOE VERA LEAF (UNII: ZY81Z83H0X) CARBOXYPOLYMETHYLENE (UNII: 0A5MM307FC) GLYCERIN (UNII: PDC6A3C0OX) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) TROLAMINE (UNII: 9O3K93S3TK) .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) FD&C RED NO. 40 (UNII: WZB9127XOA) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:29500-9416-1 30 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 03/01/2018 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part333E 03/01/2018 Labeler - GL 360 (966155082) Registrant - GL 360 (966155082)