Gerigentle-Bacitracin zinc

Gerigentle-Bacitracin zinc

Drug Labeling and Warnings

Drug Details

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GERIGENTLE-BACITRACIN ZINC- bacitracin zinc ointment 
Geri-Gentle Corporation

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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Gerigentle-Bacitracin zinc

Drug Facts

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

  • In the eyes
  • Over large areas of the body
  • If you are allergic to any of the ingredients
  • Longer than 7 days unless directed by a physician

Consult a doctor before use in cases of

  • Deep or puncture wounds
  • Animal Bites
  • Serious Burns

Stop usage and consult a doctor if

  • Conditions persist or get worse
  • Rash or other allergic reaction develops

Keep out of reach of children

  • If swallowed, get medical help or contact a Poison Control Center immediately

Directions for Use

  • Clean the affected area
  • Apply a small amount of this product 1-3 times daily (an amount equal to the surface area of a fingertip)
  • May be covered with a sterile bandage

Other information

  • Store at 15°-30°C (59°-86°F)
  • Avoid excessive heat and humidity

Inactive Ingredients

Hard Paraffin, Liquid Paraffin, White Soft Paraffin and Lanolin

PRINCIPAL DISPLAY PANEL - 0.9 Gram Packet Box

GeriGentle

Bacitracin Ointment USP
FIRST AID ANTIBIOTIC 0.9 Gram

Net Wt 0.9 Gram

144 Packets

Reorder No.
16091

PRINCIPAL DISPLAY PANEL - 0.9 Gram Packet Box
GERIGENTLE-BACITRACIN ZINC 
bacitracin zinc ointment
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 69771-106
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Bacitracin Zinc (UNII: 89Y4M234ES) (Bacitracin - UNII:58H6RWO52I) Bacitracin500 [USP'U]  in 1 g
Inactive Ingredients
Ingredient NameStrength
Paraffin (UNII: I9O0E3H2ZE)  
Mineral Oil (UNII: T5L8T28FGP)  
Petrolatum (UNII: 4T6H12BN9U)  
Lanolin (UNII: 7EV65EAW6H)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 69771-106-34144 in 1 BOX01/15/2015
10.9 g in 1 PACKET; Type 0: Not a Combination Product
2NDC: 69771-106-351 in 1 CARTON01/15/2015
228 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart333B01/15/2015
Labeler - Geri-Gentle Corporation (361663839)
Establishment
NameAddressID/FEIBusiness Operations
Glint Cosmetics Private Limited675910492MANUFACTURE(69771-106)

Revised: 1/2018
 
Geri-Gentle Corporation


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