DailyMed - MONOPOLY HAND SANITIZER- alcohol kit

Contains inactivated NDC Code(s)
NDC Code(s): 74177-959-01
Packager: K7 Design Group Inc.

Category: HUMAN OTC DRUG LABEL
DEA Schedule: None
Marketing Status: OTC monograph not final

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.

Drug Label Information

Updated December 11, 2020

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Drug Facts

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Active ingredient
Alcohol 69% v/v

Alcohol 69% v/v
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Purpose
Antiseptic

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

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

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Directions
wet hands thoroughly with product and allow to dry without wiping
- wet hands thoroughly with product and allow to dry without wiping
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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
- 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
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Inactive ingredients
Water, Glycerin, Propylene Glycol, Carbomer, Aloe Barbadensis Leaf Extract, Aminomethyl Propanol, Fragrance, Tocopheryl Acetate, Denatonium Benzoate, Yellow 5, Blue 1.

Water, Glycerin, Propylene Glycol, Carbomer, Aloe Barbadensis Leaf Extract, Aminomethyl Propanol, Fragrance, Tocopheryl Acetate, Denatonium Benzoate, Yellow 5, Blue 1.
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Company Information
MANUFACTURED FOR & DIST. BY K7 DESIGN GROUP LLC - 2433 KNAPP ST. BROOKLYN, NY 11235

MANUFACTURED FOR & DIST. BY K7 DESIGN GROUP LLC

2433 KNAPP ST. BROOKLYN, NY 11235

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Product Packaging

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INGREDIENTS AND APPEARANCE

Product Information

MONOPOLY HAND SANITIZER alcohol kit

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:74177-959

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:74177-959-01	1 in 1 KIT; Type 0: Not a Combination Product	12/11/2020

Part #	Package Quantity	Total Product Quantity
Quantity of Parts
Part 1	1 BOTTLE, PLASTIC	89 mL
Part 2	1 BOTTLE, PLASTIC	89 mL
Part 3	1 TUBE	3.4 g

Part 1 of 3

KIWI SCENT HAND SOAP other personal cleanliness products soap

Product Information
Route of Administration	TOPICAL

Ingredient Kind	Ingredient Name	Quantity
Other Ingredients
INGR	METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)
INGR	FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
INGR	METHYLCHLOROISOTHIAZOLINONE (UNII: DEL7T5QRPN)
INGR	WATER (UNII: 059QF0KO0R)
INGR	SODIUM LAURETH SULFATE (UNII: BPV390UAP0)
INGR	SODIUM COCOYL GLYCINATE (UNII: XLU9KH03XM)
INGR	EDETATE DISODIUM (UNII: 7FLD91C86K)
INGR	COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)
INGR	SODIUM CHLORIDE (UNII: 451W47IQ8X)
INGR	CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1		89 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product

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

Part 2 of 3

MANGO SCENT HAND SANITIZER alcohol gel

Product Information
Route of Administration	TOPICAL

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

Ingredient Name	Strength
Inactive Ingredients
WATER (UNII: 059QF0KO0R)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
GLYCERIN (UNII: PDC6A3C0OX)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
DENATONIUM BENZOATE (UNII: 4YK5Z54AT2)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)
AMINOMETHYLPROPANOL (UNII: LU49E6626Q)
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1		89 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product

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

Part 3 of 3

CHERRY LIP BALM lipstick lipstick

Product Information
Route of Administration	TOPICAL

Ingredient Kind	Ingredient Name	Quantity
Other Ingredients
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)

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

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

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

Labeler - K7 Design Group Inc. (080357784)

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	RxCUI	RxNorm NAME	RxTTY
1	2287763	ethanol 69 % Topical Gel	PSN
2	2287763	ethanol 0.69 ML/ML Topical Gel	SCD
3	2287763	ethanol 69 % Topical Gel	SY

Label: MONOPOLY HAND SANITIZER- alcohol kit

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Drug Label Information

When using this product

Stop use and ask a doctor if

Keep out of reach of children.

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Label: MONOPOLY HAND SANITIZER- alcohol kit

View Package Photos

Drug Label Info

Safety

Related Resources

More Info For This Drug

Drug Label Information

When using this product

Stop use and ask a doctor if

Keep out of reach of children.

Find additional resources

Safety

Related Resources

More Info on this Drug

MONOPOLY HAND SANITIZER- alcohol kit

Number of versions: 1

MONOPOLY HAND SANITIZER- alcohol kit

MONOPOLY HAND SANITIZER- alcohol kit

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MONOPOLY HAND SANITIZER- alcohol kit

If this SPL contains inactivated NDCs listed by the FDA initiated compliance action, they will be specified as such.