Bacitraycin Plus: Package Insert and Label Information

BACITRAYCIN PLUS- pramoxine hydrochloride and bacitracin zinc ointment
First Aid Research Corp

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.

Active ingredients (in each gram) Purposes

Bacitracin zinc 500 units…………First aid antibiotic

Parmoxine HCl 10 mg……………External analgesic

Uses

  • first aid to help prevent infection and for the temporary relief of pain in minor:
  • cuts
  • scrapes
  • burns

For external use only

Do no use

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

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
  • symptoms persist for more than 1 week, or clear up and occur again within a few days
  • condition persists or gets worse
  • redness, irritation, swelling, or pain persists or increases
  • rash or other allergic reactin develops

If pregnant or breast-feeding, ask a health professional before use.

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

Directions

  • adults and children 2 years of age and 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
  • children under 2 years of age: ask a doctor

Other information

  • store at room temperature 20-25°C (68-77°F)

Inactive ingredients aloe vera oil, petrolatum

Dirtributed by:

FIRST AID RESEARCH CORP.

Jupiter, FL 33478 Made in China

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BACITRAYCIN PLUS
bacitracin zinc and pramoxine hydrochloride ointment
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:75983-056
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
PRAMOXINE HYDROCHLORIDE (PRAMOXINE) PRAMOXINE HYDROCHLORIDE 10 mg in 1 g
BACITRACIN ZINC (BACITRACIN) BACITRACIN 500 [USP’U] in 1 g
Inactive Ingredients
Ingredient Name Strength
ALOE VERA LEAF
METHYLPARABEN
PETROLATUM
PROPYLPARABEN
STEARYL ALCOHOL
LIGHT MINERAL OIL
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:75983-056-01 1 TUBE in 1 BOX contains a TUBE
1 28 g in 1 TUBE This package is contained within the BOX (75983-056-01)
2 NDC:75983-056-02 1 TUBE in 1 BOX contains a TUBE
2 28 g in 1 TUBE This package is contained within the BOX (75983-056-02)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph final part333B 01/09/2019
Labeler — First Aid Research Corp (089405927)

Revised: 10/2020 First Aid Research Corp

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