AVON HEXASHIELD TRIPLE ANTIBIOTIC WITH PAIN RELIEF- bacitracin zinc, neomycin sulfate, polymyxin b sulfate, pramoxine hcl ointme

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

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Active ingredient:
POLYMYXIN B SULFATE (UNII: 19371312D4) (POLYMYXIN B - UNII:J2VZ07J96K), NEOMYCIN SULFATE (UNII: 057Y626693) (NEOMYCIN - UNII:I16QD7X297), BACITRACIN ZINC (UNII: 89Y4M234ES) (BACITRACIN - UNII:58H6RWO52I), PRAMOXINE HYDROCHLORIDE (UNII: 88AYB867L5) (PRAMOXINE - UNII:068X84E056)
Available from:
Tai Guk Pharm. Co., Ltd.
Administration route:
TOPICAL
Prescription type:
OTC DRUG
Therapeutic indications:
First aid antibiotic External analgesic first aid to help prevent infection and for temporary relief of pain or discomfort in minor: - cuts - scrapes - burns
Authorization status:
OTC monograph final
Authorization number:
43136-100-01

AVON HEXASHIELD TRIPLE ANTIBIOTIC WITH PAIN RELIEF- bacitracin zinc, neomycin

sulfate, polymyxin b sulfate, pramoxine hcl ointment

Tai Guk Pharm. Co., 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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AVON HeXashield Triple Antibiotic Ointment with Pain Relief

Active Ingredients (in each gram)

Bacitracin Zinc 500 units

Neomycin Sulfate 3.5 mg

Polymyxin B Sulfate 10,000 units

Pramoxine HCl 10 mg

Purpos e

First aid antibiotic

External analgesic

Us es

first aid to help prevent infection and for temporary relief of pain or discomfort in minor:

cuts

scrapes

burns

Warnings

For external use only.

Do not use

if you are allergic to any of the ingredients

in the eyes

over large areas of the body

Ask a doctor before use if you have

deep or puncture wounds

animal bites

serious burns

Stop use and ask a doctor if

you need to use longer than 1 week

condition persists or gets worse

symptoms persist for more than 1 week, or clear up and occur again within a few days

rash or other allergic reaction develops

Keep out of reach of children.

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

Directions

adults and children 2 years of age or older :

clean the affected area

apply a small amount of this product (an amount equal to the surface area of the tip of a finger) on the

area 1 to 3 times daily

may be covered with a sterile bandage

children under 2 years of age: ask a doctor

Other information

store at room temperature

Lot No. & Exp. Date: see box or see crimp of tube

Inactive Ingredients

ethanol, methylparaben, mineral oil, petrolatum, polyoxyl 40 stearate, propylparaben

Questions or comments?

Call toll free 1-800-FOR-AVON

www.avon.com

Principal Display Panel

Compare to the active ingredient in Neosporin

Plus Pain Relief

Helps prevent infection & relieves pain in minor cuts, scrapes & burns

MAXIMUM STRENGTH

TRIPLE ANTIBIOTIC

PAIN RELIEF

AVON

HeXashield

TRIPLE ANTIBIOTIC OINTMENT WITH PAIN RELIEF

BACITRACIN ZINC / NEOMYCIN SULFATE / POLYMYXIN B SULFATE / PRAMOXINE HCl

NET WT 1 oz (28g)

AVON HEXASHIELD TRIPLE ANTIBIOTIC WITH PAIN RELIEF

bacitracin zinc, neomycin sulfate, polymyxin b sulfate, pramoxine hcl ointment

Product Information

Product T ype

HUMAN OTC DRUG

Ite m Code (Source )

NDC:43136 -10 0

Route of Administration

TOPICAL

Active Ingredient/Active Moiety

Ingredient Name

Basis of Strength

Stre ng th

PO LYMYXIN B SULFATE (UNII: 19 371312D4) (POLYMYXIN B -

UNII:J2VZ0 7J9 6 K)

POLYMYXIN B

10 0 0 0 [USP'U]

in 1 g

NEO MYCIN SULFATE (UNII: 0 57Y6 26 6 9 3) (NEOMYCIN - UNII:I16 QD7X29 7)

NEOMYCIN

3.5 mg in 1 g

BACITRACIN ZINC (UNII: 8 9 Y4M234ES) (BACITRACIN - UNII:58 H6 RWO52I)

BACITRACIN

50 0 [USP'U] in 1 g

PRAMO XINE HYDRO CHLO RIDE (UNII: 8 8 AYB8 6 7L5) (PRAMOXINE -

UNII:0 6 8 X8 4E0 56 )

PRAMOXINE

HYDROCHLORIDE

10 mg in 1 g

Inactive Ingredients

Ingredient Name

Stre ng th

PETRO LATUM (UNII: 4T6 H12BN9 U)

Packag ing

Tai Guk Pharm. Co., Ltd.

#

Item Code

Package Description

Marketing Start Date

Marketing End Date

1

NDC:43136 -10 0 -0 1

1 in 1 CARTON

0 7/31/20 19

1

28 g in 1 TUBE; Type 0 : No t a Co mbinatio n Pro duct

Marketing Information

Marke ting Cate gory

Application Numbe r or Monograph Citation

Marke ting Start Date

Marke ting End Date

OTC mo no graph final

pa rt333B

0 7/31/20 19

Labeler -

T ai Guk Pharm. Co., Ltd. (689060246)

Registrant -

New Avon LLC (080143520)

Establishment

Name

Ad d re s s

ID/FEI

Busine ss Ope rations

Tai Guk Pharma. Co ., Ltd.

6 8 9 0 6 0 246

ma nufa c ture (43136 -10 0 )

Revised: 8/2019

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