Triple Antiobiotic (Triple Antibiotic Ointment) Ointment [Davemed Healthcare Co., Ltd.] -

TRIPLE ANTIOBIOTIC (TRIPLE ANTIBIOTIC OINTMENT) OINTMENT [DAVEMED HEALTHCARE CO., LTD.]
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NDC	70897-003-01, 70897-003-02, 70897-003-03
Set ID	39d34a43-a672-6e9c-e054-00144ff8d46c
Category	HUMAN OTC DRUG LABEL
Packager	Davemed Healthcare Co., Ltd.
Generic Name
Product Class	Aminoglycoside Antibacterial
Product Number
Application Number	PART333B

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DOSAGE & ADMINISTRATION
DIRECTIONS
- clean affected area
- apply small amount not more than 3 times daily
- maybe covered with a sterile bandage
- children under 2 years of age ask a doctor
INDICATIONS & USAGE

USES

First aid to help prevent infection and for the temporary relief of pain and itching associated with minor cuts, scrapes and burns
WARNINGS

FOR EXTERNAL USE ONLY
KEEP OUT OF REACH OF CHILDREN

KEEP OUT OF REACH OF CHILDREN

If ingested contact a poison control center right away.
ACTIVE INGREDIENT

NEOMYCIN

BACITRACIN

PRAMOXINE HCI
INACTIVE INGREDIENT

Petrolatum
PURPOSE

First Aid Antibiotic. For temporary relief of pain associated with minor burns.
PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

TRIPLE ANTIOBIOTIC
triple antibiotic ointment ointment

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
POLYMYXIN B SULFATE (UNII: 19371312D4) (POLYMYXIN B - UNII:J2VZ07J96K)	POLYMYXIN B	5000 [iU] in 1 g
NEOMYCIN SULFATE (UNII: 057Y626693) (NEOMYCIN - UNII:I16QD7X297)	NEOMYCIN	5 mg in 1 g
BACITRACIN ZINC (UNII: 89Y4M234ES) (BACITRACIN - UNII:58H6RWO52I)	BACITRACIN	400 [iU] in 1 g

Ingredient Name	Strength
Inactive Ingredients
PETROLATUM (UNII: 4T6H12BN9U)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:70897-003-01	0.9 g in 1 PACKET; Type 0: Not a Combination Product	08/11/2016
2	NDC:70897-003-02	14.2 g in 1 TUBE; Type 0: Not a Combination Product	08/11/2016
3	NDC:70897-003-03	28.4 g in 1 TUBE; Type 0: Not a Combination Product	08/11/2016

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part333B	08/11/2016

Labeler - Davemed Healthcare Co., Ltd. (529128716)

Name	Address	ID/FEI	Business Operations
Establishment
Davemed Healthcare Co., Ltd.		529128716	manufacture(70897-003)

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Medic