CUPCAKE SCENTED HAND SANITIZER- alcohol gel

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

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Active ingredient:
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)
Available from:
FOURSTAR GROUP USA, INC.
Administration route:
TOPICAL
Prescription type:
OTC DRUG
Therapeutic indications:
hand sanitizer to help reduce bacteria on skin
Authorization status:
OTC monograph not final
Authorization number:
80684-012-01

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CUPCAKE SCENTED HAND SANITIZER- alcohol gel

FOURSTAR GROUP USA, 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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Cupcake Scented Hand Sanitizer Gel

Drug Facts

Active ingredient

Ethyl Alcohol, 70% v/v

Purpose

Antimicrobial

Uses

hand sanitizer to help reduce bacteria on skin

Warnings

For external use only.

Flammable, keep away from fire or flame.

Do not use

in or near the eyes In case of contact, rinse eyes thoroughly with water.

Stop use and ask a doctor if

irritation, excessive redness or rash develops.

Keep out of reach of children.

Supervise children under 6 years of age when using this product to avoid swallowing. If swallowed,

get medical help or contact a Poison Control Center right away.

Directions

Put a dime sized drop onto hands and rub together briskly until dry.

Other information

Store below 110°F (43°C)

Inactive ingredients

water, carbomer, fragrance, triethanolamine, blue 1

Package Labeling:

CUPCAKE SCENTED HAND SANITIZER

alcohol gel

Product Information

Product T ype

HUMAN OTC DRUG

Ite m Code (Source )

NDC:8 0 6 8 4-0 12

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

0 .7 mL in 1 mL

Inactive Ingredients

Ingredient Name

Stre ng th

WATER (UNII: 0 59 QF0 KO0 R)

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

TRO LAMINE (UNII: 9 O3K9 3S3TK)

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

Packag ing

#

Item Code

Package Description

Marketing Start Date

Marketing End Date

1

NDC:8 0 6 8 4-0 12-0 1

29 mL in 1 BOTTLE; Type 0 : No t a Co mbinatio n Pro duct

12/17/20 20

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 rt333E

12/17/20 20

FOURSTAR GROUP USA, INC.

Labeler -

FOURST AR GROUP USA, INC. (140099503)

Revised: 12/2020

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