BABINGTONSOAPCO- hand sanitizer gel gel

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

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Active ingredient:
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)
Available from:
Babington Soap Co Limited
Administration route:
TOPICAL
Prescription type:
OTC DRUG
Therapeutic indications:
Antiseptic, Hand Sanitizer Hand Sanitizer to help reduce bacteria on the skin. Stop use and ask a doctor if irritation and redness develop.
Authorization status:
OTC monograph not final
Authorization number:
80104-111-11, 80104-111-12

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BABINGTONSOAPCO- hand sanitizer gel gel

Babington Soap Co Limited

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.

----------

Babington Soap Co. 55ML

Active Ingredient(s)

Alcohol 66% v/v. Purpose: Antiseptic

Purpos e

Antiseptic, Hand Sanitizer

Us e

Hand Sanitizer to help reduce bacteria on the skin.

Warnings

Flammable. Keep away from fire or flame

For external use only.

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 and redness develop.

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 and redness develop.

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

away.

Directions

Dispense onto dry hands and rub together thoroughly and then allow product to dry without rinsing.

Do not use on open skin or wounds.

Not for use by children under 6 years old.

Other information

Do not store above 106F.

If skin irritation or rash occurs discontinue use immediately.

May discolor some fabrics.

Inactive ingredients

Aqua, Polyquaternium 10, Chitosan, lactic acid organic, lemongrass oil.

Package Label - Principal Display Panel

55 mL NDC: 80104-111-11

BABINGTONSOAPCO

hand sanitizer gel gel

Product Information

Product T ype

HUMAN OTC DRUG

Ite m Code (Source )

NDC:8 0 10 4-111

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

6 6 mL in 10 0 mL

Inactive Ingredients

Ingredient Name

Stre ng th

PO LYQ UATERNIUM-10 ( 2 0 0 0 0 MPA.S AT 2 %) (UNII: N2GK4S7X4T)

CYMBO PO GO N SCHO ENANTHUS O IL (UNII: XE7K56 8 ILO)

WATER (UNII: 0 59 QF0 KO0 R)

LACTIC ACID (UNII: 33X0 4XA5AT)

CHITO SAN MEDIUM MO LECULAR WEIGHT ( 2 0 0 -4 0 0 MPA.S) (UNII: 5GV0 9 YMO52)

Babington Soap Co Limited

Packag ing

#

Item Code

Package Description

Marketing Start Date

Marketing End Date

1

NDC:8 0 10 4-111-11

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

12/0 2/20 20

2

NDC:8 0 10 4-111-12

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

12/0 2/20 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

12/0 2/20 20

Labeler -

Babington Soap Co Limited (226050699)

Establishment

Name

Ad d re s s

ID/FEI

Busine ss Ope rations

Geo rge K Ho o d Legacy LLP

12236 0 9 9 4

ma nufa c ture (8 0 10 4-111)

Revised: 12/2020

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