BACLEZENE- neomycin sulfate cream

Baclezene by

Drug Labeling and Warnings

Baclezene by is a Otc medication manufactured, distributed, or labeled by Curazene, LLC, Ultra Seal Corp.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active Ingredient: (in each 0.9 gram) : Neomycin Sulfate, 5mg

INDICATIONS & USAGE

Uses: First aid to prevent infection in minor cuts, scrapes, burns

PURPOSE

Purpose: First Aid Antibiotic

WARNINGS

Warnings: For external use only.  Do not use: if you are allergic to any of the ingredients, in the eyes, over large areas of the body.  Ask a doctor before use if you have: large puncture wounds, animal bites, serious burns. 

Stop use and ask a doctor if: you need to use longer than one week, condition persists or gets worse, symptoms persist for more than one week or clear up and occur again within a few days, 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.

DOSAGE & ADMINISTRATION

Adults and children over 2 years of age or older: Clean the affected area.  Apply contents of packet to surface of affected area 2 times daily.  Gently rub in. Children under 2 years of age: Ask a doctor.

INACTIVE INGREDIENT

Inactive Ingredients:Ascorbic Acid, Benzoic Acid, Chlorphenesin, Citric Acid, Glycerin, Glycerol MS S.E., Magnesium Stearate, Methyl Paraben, Phenoxyethanol, Polysorbate 80, SDBS, Trisodium Citrate, Stearic Acid, USP Water, White Petrolatum

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

BACLEZENE 
neomycin sulfate cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 52599-282
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
NEOMYCIN SULFATE (UNII: 057Y626693) (NEOMYCIN - UNII:I16QD7X297)	NEOMYCIN SULFATE	5 mg  in 0.9 g

Inactive Ingredients
Ingredient Name	Strength
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
GLYCERIN (UNII: PDC6A3C0OX)
POLYSORBATE 80 (UNII: 6OZP39ZG8H)
PETROLATUM (UNII: 4T6H12BN9U)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
SODIUM CITRATE (UNII: 1Q73Q2JULR)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
METHYLPARABEN (UNII: A2I8C7HI9T)
CHLORPHENESIN (UNII: I670DAL4SZ)
BENZOIC ACID (UNII: 8SKN0B0MIM)
ASCORBIC ACID (UNII: PQ6CK8PD0R)
MAGNESIUM STEARATE (UNII: 70097M6I30)
STEARIC ACID (UNII: 4ELV7Z65AP)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 52599-282-83	20 in 1 CARTON	06/19/2014
1	NDC: 52599-282-82	0.9 g in 1 PACKET; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part333B	06/19/2014

Labeler - Curazene, LLC (005078008)

Registrant - Curazene, LLC (005078008)

Establishment
Name	Address	ID/FEI	Business Operations
Ultra Seal Corp.		085752004	manufacture(52599-282)