MEDPRIDE FIRST AID- bacitracin zinc ointment

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

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Active ingredient:
BACITRACIN ZINC (UNII: 89Y4M234ES) (BACITRACIN - UNII:58H6RWO52I)
Available from:
Shield Line LLC
Administration route:
TOPICAL
Prescription type:
OTC DRUG
Therapeutic indications:
First Aid Antibiotic ■ first aid to help prevent infection in minor ■ cuts ■ scrapes ■ burns ■ Not for opthalmic use Do not use ■ in the eyes ■ if you are allergic to any of the ingredients ■ over large areas of the body longer than 1 week unless directed by a doctor ■ deep or puncture wounds ■ animal bites ■ serious burns ■ the condition persists or gets worse ■ a rash or other allergic reaction develops
Authorization status:
OTC monograph final
Authorization number:
52410-3035-2, 52410-3035-3, 52410-3035-4, 52410-3035-5, 52410-3035-6

MEDPRIDE FIRST AID- bacitracin zinc ointment

Shield Line LLC

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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Medpride Bacitracin Zinc

Active Ingredient (in each gram)

Bacitracin Zinc (equal to 500 bacitracin units)

Purpose

First Aid Antibiotic

Uses

■ first aid to help prevent infection in minor ■ cuts ■ scrapes ■ burns

Warnings

For external use only

Do not use

■ Not for opthalmic use Do not use ■ in the eyes ■ if you are allergic to any of the ingredients ■ over

large areas of the body longer than 1 week unless directed by a doctor

Ask a doctor before use in case of

■ deep or puncture wounds

■ animal bites ■ serious burns

Stop use and ask a doctor if

■ the condition persists or gets worse

■ a rash or other allergic reaction develops

Keep out of reach of children

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

away.

Directions

■ 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

Other Information

■ store at room temperature 15-30C (59-86F)

■ avoid excessive heat and humidity

Inactive Ingredients

hard paraffin, liquid paraffin, white soft paraffin, lanolin

Package Label

MEDPRIDE FIRST AID

bacitracin zinc ointment

Product Information

Product T ype

HUMAN OTC DRUG

Ite m Code (Source )

NDC:52410 -30 35

Route of Administration

TOPICAL

Active Ingredient/Active Moiety

Ingredient Name

Basis of Strength

Stre ng th

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

BACITRACIN

50 0 [USP'U] in 1 g

Inactive Ingredients

Ingredient Name

Stre ng th

PARAFFIN (UNII: I9 O0 E3H2ZE)

MINERAL O IL (UNII: T5L8 T28 FGP)

PETRO LATUM (UNII: 4T6 H12BN9 U)

LANO LIN (UNII: 7EV6 5EAW6 H)

Packag ing

#

Item Code

Package Description

Marketing Start Date

Marketing End Date

1

NDC:52410 -30 35-2

0 .9 g in 1 PACKET; Type 0 : No t a Co mbinatio n Pro duct

0 5/30 /20 13

Shield Line LLC

2

NDC:52410 -30 35-3

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

0 5/30 /20 13

3

NDC:52410 -30 35-4

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

0 5/30 /20 13

4

NDC:52410 -30 35-5

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

0 5/30 /20 13

5

NDC:52410 -30 35-6

425 g in 1 JAR; Type 0 : No t a Co mbinatio n Pro duct

0 5/30 /20 13

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 5/30 /20 13

Labeler -

Shield Line LLC (078518916)

Revised: 8/2020

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