TRIPLE ANTIBIOTIC- polymyxin b sulfate,neomycin sulfate,bacitracin ointment

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

POLYMYXIN B SULFATE (UNII: 19371312D4) (POLYMYXIN B - UNII:J2VZ07J96K), NEOMYCIN SULFATE (UNII: 057Y626693) (NEOMYCIN - UNII:I16QD7X297), BACITRACIN (UNII: 58H6RWO52I) (BACITRACIN - UNII:58H6RWO52I), LIDOCAINE (UNII: 98PI200987) (LIDOCAINE - UNII:98PI200987)

Available from:

Shandong Ruian Pharmaceutical Co.,Ltd.

Administration route:

TOPICAL

Prescription type:

OTC DRUG

Therapeutic indications:

• if you are allergic to any of the ingredients • in the eyes • over large areas of the body 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

Summary of Product characteristics

TRIPLE ANTIBIOTIC- POLYMYXIN B SULFATE,NEOMYCIN
SULFATE,BACITRACIN OINTMENT
SHANDONG RUIAN PHARMACEUTICAL 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._
----------
For external use only.
white petrolatum
• if you are allergic to any of the ingredients
• in the eyes
• over large areas of the body
If swallowed, get medical help or contact a Poison Control Center
right away
First aid antibiotic
External analgesic
• deep or puncture wounds
• animal bites
• serious burns
POLYMYXIN B SULFATE;
NEOMYCIN SULFATE;
BACITRACIN ZINC;
PRAMOXINE HYDROCHLORIDE
store at 10-30°C
• 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
first aid to help prevent infection and for temporary relief of pain
or discomfort in minor:
• cuts
• scrapes
• burns
NDC:82199-530-12 28.3 g in 1 TUBE
NDC:82199-530-11 14.2 g in 1 TUBE
TRIPLE ANTIBIOTIC
polymyxin b sulfate,neomycin sulfate,bacitracin ointment
PRODUCT INFORMATION
PRODUCT TYPE
HUMAN OTC DRUG
ITEM CODE (SOURCE)
NDC:82199-530
ROUTE OF ADMINISTRATION
TOPICAL
ACTIVE INGREDIENT/ACTIVE MOIETY
INGREDIENT NAME
BASIS OF
STRENGTH
STRENGTH
POLYMYXIN B SULFATE (UNII: 19371312D4) (POLYMYXIN B -
POLYMYXIN B
5000 [USP'U]
Shandong Ruian Pharmaceutical Co.,Ltd.
UNII:J2VZ 07J96K)
POLYMYXIN B
in 1 g
NEOMYCIN SULFATE (UNII: 057Y626693) (NEOMYCIN - UNII:I16QD7X297)
NEOMYCIN SULFATE
3500 [USP'U]
in 1 g
BACITRACIN (UNII: 58H6RWO52I) (BACITRACIN - UNII:58H6RWO52I)
BACITRACIN
500 [USP'U] in 1 g
LIDOCAINE (UNII: 98PI200987) (LIDOCAINE - UNII:98PI200987)
LIDOCAINE
40 mg in 1 g
INACTIVE INGREDIENTS
INGREDIENT NAME
STRENGTH
PETROLATUM (UNII: 4T6H12BN9U)
PRODUCT CHARACTERISTICS
COLOR
yell