LUCKY SUPERSOFT 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:
Anicare Pharmaceuticals pvt. Ltd.
Administration route:
TOPICAL
Prescription type:
OTC DRUG
Therapeutic indications:
First aid antibiotic helps prevent infection in: ■ minor cuts ■ scrapes ■ burns ■ in eyes ■ on large areas of the body ■ deep or puncture wounds ■ animal bites ■ serious burns When using this product ■ do not use longer than 1 week ■ condition lasts or gets worse ■ rash or other allergic reaction develops
Authorization status:
OTC monograph final
Authorization number:
47046-174-01

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LUCKY SUPERSOFT FIRST AID- bacitracin zinc ointment

Anicare Pharmaceuticals pvt. 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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first aid

Active Ingredient (in each gram)

Bacitracin zinc 500 units

Purpose

First aid antibiotic

Uses

helps prevent infection in: ■ minor cuts ■ scrapes ■ burns

Warnings

For external use only

Alergy alert

do not use if allergic to any of the ingredients

Do not use

■ in eyes ■ on large areas of the body

Ask a doctor before use if you have

■ deep or puncture wounds ■ animal bites ■ serious burns

When using this product ■ do not use longer than 1 week

When using this product

do not use longer than 1 week

Stop use and ask a doctor if

■ condition lasts or gets worse ■ 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

■ 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 15-25C (59-77F)

■ do not use if tube seal under cap is broken, missing or if the tube tip is cut prior to opening

Inactive ingredients

white petrolatum

Package Label

LUCKY SUPERSOFT FIRST AID

bacitracin zinc ointment

Product Information

Product T ype

HUMAN OTC DRUG

Ite m Code (Source )

NDC:470 46 -174

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

Anicare Pharmaceuticals pvt. Ltd.

Inactive Ingredients

Ingredient Name

Stre ng th

PETRO LATUM (UNII: 4T6 H12BN9 U)

Packag ing

#

Item Code

Package Description

Marketing Start Date

Marketing End Date

1

NDC:470 46 -174-0 1

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

0 3/0 1/20 15

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 1/31/20 15

Labeler -

Anicare Pharmaceuticals pvt. Ltd. (916837425)

Revised: 12/2020

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