ANTIBACTERIAL 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:
ASC Marketing LTD
Administration route:
TOPICAL
Prescription type:
OTC DRUG
Therapeutic indications:
- for handwashing to decrease bacteria on the skin.  - recommended for repeated use.
Authorization status:
OTC monograph not final
Authorization number:
73145-003-01, 73145-003-02, 73145-003-03

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ANTIBACTERIAL HAND SANITIZER- alcohol gel

ASC Marketing LTD

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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Antibacterial Hand Sanitizer

Drug Facts

Active ingredient

Ethyl alcohol 70%

Purpose

Antiseptic

Uses

for handwashing to decrease bacteria on the skin.

recommended for repeated use.

Warnings

For external use only.

When using this product

Do not use in eyes.

Discontinue use if irritation and redness develop.

Flammable, keep away from fire or flame.

Keep out of reach of children.

If swallowed, get medical help or contact a Poison Control Centre right away.

If pregnant or breast-feeding,

ask a health professional before use.

Directions

wet hands thoroughly with product.

briskly rub hands together until dry.

Inactive ingredients

Water, Glycerin, Propylene Glycol, Carbomer, Triethanolamine, Aloe Barbadensis Leaf

Juice, Fragrance

Package Labeling:

Package Labeling:

Package Labeling:73145-003-03

ANTIBACTERIAL HAND SANITIZER

alcohol gel

Product Information

Product T ype

HUMAN OTC DRUG

Ite m Code (Source )

NDC:73145-0 0 3

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

ASC Marketing LTD

WATER (UNII: 0 59 QF0 KO0 R)

GLYCERIN (UNII: PDC6 A3C0 OX)

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

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

TRO LAMINE (UNII: 9 O3K9 3S3TK)

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

Packag ing

#

Item Code

Package Description

Marketing Start Date

Marketing End Date

1

NDC:73145-0 0 3-0 1

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

11/19 /20 20

2

NDC:73145-0 0 3-0 2

6 0 mL in 1 BOTTLE; Type 0 : No t a Co mbinatio n Pro duct

11/19 /20 20

3

NDC:73145-0 0 3-0 3

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

0 1/20 /20 21

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

11/19 /20 20

Labeler -

ASC Marketing LT D (117025198)

Revised: 1/2021

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