MY LITTLE PONY COTTON CANDY HAND SANITIZER AND LIP BALM- alcohol kit

United States - English - NLM (National Library of Medicine)

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Active ingredient:
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)
Available from:
K7 Design Group Inc.
Prescription type:
OTC DRUG
Therapeutic indications:
Antiseptic for hand-washing to decrease bacteria on the skin, only when water is not available
Authorization status:
OTC monograph not final
Authorization number:
74177-969-01

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MY LITTLE PONY COTTON CANDY HAND SANITIZER AND LIP BALM- alcohol

K7 Design Group Inc.

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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My Little Pony Cotton Candy Hand Sanitizer and Lip Balm Kit

Drug Facts

Active ingredient

Alcohol 69% v/v

Purpos e

Antiseptic

Us e

for hand-washing to decrease bacteria on the skin, only when water is not available

Warnings

For external use only

Flammable, keep away from fire and flames

When using this product

do not get into eyes.

if contact occurs, rinse eyes thoroughly with water

Stop use and ask a doctor if

irritation and redness develop

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 allow to dry without wiping

Other information

Store at 68F to 77F (20C - 25C)

Do not store above 110F (43C)

You may report a serious adverse reaction to this product to Report Reaction, LLC, PO Box 22,

Plainsboro, NJ 08536

Inactive ingredients

Water, Glycerin, Propylene Glycol, Carbomer, Aloe Barbadensis Leaf Extract, Aminomethyl Propanol,

Fragrance, Tocopheryl Acetate, Denatonium Benzoate, Red 40, Blue 1.

Company Information

MANUFACTURED FOR & DIST. BY K7 DESIGN GROUP LLC

2433 KNAPP ST. BROOKLYN, NY 11235

Product Packaging

MY LITTLE PONY COTTON CANDY HAND SANITIZER AND LIP BALM

alcohol kit

Product Information

Product T ype

HUMAN OTC DRUG

Ite m Code (Source )

NDC:74177-9 6 9

Packag ing

#

Item Code

Package Description

Marketing Start Date

Marketing End Date

1

NDC:74177-9 6 9 -0 1

1 in 1 KIT; Type 0 : No t a Co mbinatio n Pro duct

12/11/20 20

Quantity of Parts

Part #

Package Quantity

Total Product Quantity

Pa rt 1

1 BOTTLE, PLASTIC

30 mL

Pa rt 2

1 TUBE

3.4 g

Part 1 of 2

COTTON CANDY HAND SANITIZER

alcohol gel

Product Information

Route of Administration

TOPICAL

Active Ingredient/Active Moiety

Ingredient Name

Basis of Strength

Stre ng th

ALCO HO L (UNII: 3K9 9 58 V9 0 M) (ALCOHOL - UNII:3K9 9 58 V9 0 M)

ALCOHOL

6 9 mL in 10 0 mL

Inactive Ingredients

Ingredient Name

Stre ng th

WATER (UNII: 0 59 QF0 KO0 R)

.ALPHA.-TO CO PHERO L ACETATE (UNII: 9 E8 X8 0 D2L0 )

GLYCERIN (UNII: PDC6 A3C0 OX)

ALO E VERA LEAF (UNII: ZY8 1Z8 3H0 X)

DENATO NIUM BENZO ATE (UNII: 4YK5Z54AT2)

FD&C BLUE NO . 1 (UNII: H3R47K3TBD)

PRO PYLENE GLYCO L (UNII: 6 DC9 Q16 7V3)

CARBO MER HO MO PO LYMER, UNSPECIFIED TYPE (UNII: 0 A5MM30 7FC)

AMINO METHYLPRO PANO L (UNII: LU49 E6 6 26 Q)

FD&C RED NO . 4 0 (UNII: WZB9 127XOA)

Packag ing

#

Item

Co de

Package Description

Marketing Start

Date

Marketing End Date

1

30 mL in 1 BOTTLE, PLASTIC; Type 0 : No t a Co mbinatio n

Pro duc t

Marketing Information

Marke ting Cate gory

Application Numbe r or Monograph Citation

Marke ting Start Date

Marke ting End Date

OTC mo no graph no t final

pa rt333A

12/11/20 20

Part 2 of 2

LIP BALM

lipstick lipstick

Product Information

Route of Administration

TOPICAL

Other Ingredients

Ingredient Kind

Ingredient Name

Quantity

INGR

ETHYLHEXYL PALMITATE (UNII: 28 6 59 9 330 9 )

K7 Design Group Inc.

INGR

SACCHARIN SO DIUM (UNII: SB8 ZUX40 TY)

INGR

PHENO XYETHANO L (UNII: HIE49 2ZZ3T)

INGR

PO LYISO BUTYLENE ( 10 0 0 MW) (UNII: 5XB3A6 3Y52)

INGR

SQ UALANE (UNII: GW8 9 575KF9 )

INGR

CERESIN (UNII: Q1LS2UJO3A)

INGR

YELLO W WAX (UNII: 2ZA36 H0 S2V)

Packag ing

#

Item Code

Package Description

Marketing Start Date

Marketing End Date

1

3.4 g in 1 TUBE; Type 0 : No t a Co mbinatio n Pro duct

Marketing Information

Marke ting Cate gory

Application Numbe r or Monograph Citation

Marke ting Start Date

Marke ting End Date

Co sme tic

Marketing Information

Marke ting Cate gory

Application Numbe r or Monograph Citation

Marke ting Start Date

Marke ting End Date

OTC mo no graph no t final

pa rt333A

12/11/20 20

Labeler -

K7 Design Group Inc. (080357784)

Revised: 12/2020

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