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:
Bell Food & Beverage Inc.
Administration route:
TOPICAL
Prescription type:
OTC DRUG
Therapeutic indications:
Antiseptic Hand Sanitizer to help reduce bacteria that potentially can cause disease. For use when soap and water are not available. - in children less than 2 months of age - on open skin wounds Stop use and ask a doctor if irritation or rash occurs. These may be signs of a serious condition.
Authorization status:
OTC monograph not final
Authorization number:
73806-0004-1, 73806-0004-2, 73806-0004-3

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HAND SANITIZER- alcohol gel

Bell Food & Beverage 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.

----------

Active Ingredient(s)

Alcohol 75% v/v. Purpose: Antiseptic

Purpos e

Antiseptic

Us e[s ]

Hand Sanitizer to help reduce bacteria that potentially can cause disease. For use when soap and water

are not available.

Warnings

For external use only. Flammable. Keep away from heat or flame

Do not use

in children less than 2 months of age

on open skin wounds

When using this product keep out of eyes, ears, and mouth. In case of contact with eyes, rinse eyes

thoroughly with water.

Stop use and ask a doctor if irritation or rash occurs. These may be signs of a serious condition.

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right

away.

Stop use and ask a doctor if irritation or rash occurs. These may be signs of a serious condition.

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right

away.

Directions

Place enough product on hands to cover all surfaces. Rub hands together until dry.

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

Other information

Store between 15-30C (59-86F)

Avoid freezing and excessive heat above 40C (104F)

Inactive ingredients

Aloe Barbadensis Leaf Juice, Caprylyl Glycol, CI-42090, Ethyl Macadamiate, Eucalyptus Globulus

Leaf Oil, Glycerin, Menthol, Polysorbate 80, Propylene Glycol, Safflower Glyceride, Tocopheryl

Acetate, Water, 1,2-Hexanediol

Package Label - Principal Display Panel

500 mL NDC: 73806-0004-1

1892 mL NDC: 73806-0004-2

3785mL NDC: 73806-0004-3

HAND SANITIZER

alcohol gel

Product Information

Product T ype

HUMAN OTC DRUG

Ite m Code (Source )

NDC:738 0 6 -0 0 0 4

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

75 mL in 10 0 mL

Inactive Ingredients

Ingredient Name

Stre ng th

ETHYL MACADAMIATE (UNII: ANA2NCS6 V1)

MENTHO L, UNSPECIFIED FO RM (UNII: L7T10 EIP3A)

PO LYSO RBATE 8 0 (UNII: 6 OZP39 ZG8 H)

SAFFLO WER O IL (UNII: 6 5UEH26 2IS)

EUCALYPTUS O IL (UNII: 2R0 4ONI6 6 2)

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

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

CAPRYLYL GLYCO L (UNII: 0 0 YIU5438 U)

WATER (UNII: 0 59 QF0 KO0 R)

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

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

1,2 -HEXANEDIO L (UNII: TR0 46 Y3K1G)

Bell Food & Beverage Inc.

GLYCERIN (UNII: PDC6 A3C0 OX)

Packag ing

#

Item Code

Package Description

Marketing Start

Date

Marketing End

Date

1

NDC:738 0 6 -

0 0 0 4-1

50 0 mL in 1 BOTTLE, PLASTIC; Type 0 : No t a Co mbinatio n

Pro duc t

12/0 1/20 20

2

NDC:738 0 6 -

0 0 0 4-2

18 9 2 mL in 1 BOTTLE, PUMP; Type 0 : No t a Co mbinatio n

Pro duc t

12/0 1/20 20

3

NDC:738 0 6 -

0 0 0 4-3

378 5 mL in 1 BOTTLE, PUMP; Type 0 : No t a Co mbinatio n

Pro duc t

12/0 1/20 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 rt333A

11/20 /20 20

Labeler -

Bell Food & Beverage Inc. (081550987)

Establishment

Name

Ad d re s s

ID/FEI

Busine ss Ope rations

Bell Fo o d & Beverage Inc.

0 8 1550 9 8 7

ma nufa c ture (738 0 6 -0 0 0 4)

Revised: 11/2020

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