PLAYDOH GRAPE HAND SANITIZER AND LIP BALM- alcohol kit

Playdoh Grape Hand Sanitizer and Lip Balm by

Drug Labeling and Warnings

Playdoh Grape Hand Sanitizer and Lip Balm by is a Otc medication manufactured, distributed, or labeled by K7 Design Group Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

Active ingredient

Alcohol 69% v/v

Purpose

Antiseptic

Use

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, Blue 1, Red 33.

Company Information

MANUFACTURED FOR & DIST. BY K7 DESIGN GROUP LLC

2433 KNAPP ST. BROOKLYN, NY 11235

Product Packaging

INGREDIENTS AND APPEARANCE

PLAYDOH GRAPE HAND SANITIZER AND LIP BALM 
alcohol kit

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 74177-975

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 74177-975-01	1 in 1 KIT; Type 0: Not a Combination Product	12/11/2020

Quantity of Parts
Part #	Package Quantity	Total Product Quantity
Part 1	1 BOTTLE, PLASTIC	30 mL
Part 2	1 TUBE	3.4 g

Part 1 of 2

GRAPE HAND SANITIZER 
alcohol gel

Product Information
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	69 mL  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
GLYCERIN (UNII: PDC6A3C0OX)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
DENATONIUM BENZOATE (UNII: 4YK5Z54AT2)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)
AMINOMETHYLPROPANOL (UNII: LU49E6626Q)
D&C RED NO. 33 (UNII: 9DBA0SBB0L)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1		30 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	12/11/2020

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: 2865993309)
INGR	SACCHARIN SODIUM (UNII: SB8ZUX40TY)
INGR	PHENOXYETHANOL (UNII: HIE492ZZ3T)
INGR	POLYISOBUTYLENE (1000 MW) (UNII: 5XB3A63Y52)
INGR	SQUALANE (UNII: GW89575KF9)
INGR	CERESIN (UNII: Q1LS2UJO3A)
INGR	YELLOW WAX (UNII: 2ZA36H0S2V)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1		3.4 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Cosmetic

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	12/11/2020

Labeler - K7 Design Group Inc. (080357784)