CAREONE BACITRACIN- bacitracin ointment 
AMERICAN SALES COMPANY

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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CareOne Bacitracin Ointment 1 oz 31358 (2019)

Active ingredients (each gram contains)                                                          Purpose

Bacitracin 500 units .......................................................................................First Aid Antibiotic

Uses

first aid to help prevent infection in minor cuts, scrapes, and burns

Warnings

For external use only

Do not use

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

Ask a doctor before use in case of deep or puncture wounds, animal bites, or serious burns

Stop use and ask a doctor if

  • you need to use longer than 1 week
  • condition persists or gets worse
  • rash or other allergic reaction 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

  • 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 20 o to 25 o C (68 o to 77 o F)

Inactive ingredients

aloe vera gel, mineral oil, petrolatum

DISTRIBUTED BY

FOODHOLD U.S.A. LLC

LANDOVER, MD 20785

1-877-846-9949

Made in Korea

31358

CAREONE BACITRACIN 
bacitracin ointment
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:41520-313
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BACITRACIN (UNII: 58H6RWO52I) (BACITRACIN - UNII:58H6RWO52I) BACITRACIN500 [USP'U]  in 1 g
Inactive Ingredients
Ingredient NameStrength
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
LIGHT MINERAL OIL (UNII: N6K5787QVP)  
PETROLATUM (UNII: 4T6H12BN9U)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:41520-313-281 in 1 CARTON09/14/2016
128 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart333B03/01/201209/15/2021
Labeler - AMERICAN SALES COMPANY (809183973)

Revised: 11/2021
 
AMERICAN SALES COMPANY