PROCOMYCIN- bacitracin, neomycin, polymyxin b and lidocain hydrochloride cream 
Aidarex Pharmaceuticals LLC

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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Drug Facts

Active ingredients

Bacitracin 500 units

Neomycin 3.5.mg

Polymyxin B 10,000 units

Purpose

First Aid Antibiotic

Active ingredient

Lidocaine Hydrochloride 4%

Purpose

Local Anesthetic

Uses

Warnings

For external use only.

Do not use

Consult a doctor

Stop use and consult a doctor

Keep out of reach of children.

If swallowed, get medical help or contact a Poison Control Center right away.

Directions for use

Inactive ingredients

acrylates/dimethicone coploymer, allantoin, aloe barbadensis (aloe vera) leaf juice, arachidyl alcohol, arachidyl glucoside, arnica montana flower extract, ascorbic acid (vitamin C), behenyl alcohol, beta-glucan, benzalkonium chloride, beta-glucan, butyrospermum parkii (shea) butter, C 12-15 alkyl benzoate, caprylic/capric triglyceride, cetearyl alcohol, cetearyl glucoside, cyclopentasiloxane, dimethicone, dipalmitoyl hydroxyproline, glycerin, glycine soja (soybean) oil, helianthus annuus (sunflower) seed oil, hydrolyzed mytilus edulis byssus, methylparaben, panthenol, persea gratissima (avocado) oil, phenoxyethanol, polyglyceryl-6 distearate, propylparaben, sclerotium gum, tocopherol, water (aqua)

Manufactured in the USA for:

Physician's Science and Nature, Inc.

220 Newport Center Drive, 11-634,

Newport Beach, CA 92660

www.procomycin.com

Repackaged By:
Aidarex Pharmaceuticals, LLC.
Corona, CA 92880

Package/Label Principal Display Panel

IMAGE LABEL
PROCOMYCIN 
bacitracin, neomycin, polymyxin b and lidocain hydrochloride cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:33261-788(NDC:27495-010)
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BACITRACIN (UNII: 58H6RWO52I) (BACITRACIN - UNII:58H6RWO52I) BACITRACIN500 [iU]  in 1 g
NEOMYCIN (UNII: I16QD7X297) (NEOMYCIN - UNII:I16QD7X297) NEOMYCIN0.0035 g  in 1 g
POLYMYXIN B (UNII: J2VZ07J96K) (POLYMYXIN B - UNII:J2VZ07J96K) POLYMYXIN B10000 [iU]  in 1 g
LIDOCAINE HYDROCHLORIDE (UNII: V13007Z41A) (LIDOCAINE - UNII:98PI200987) LIDOCAINE HYDROCHLORIDE ANHYDROUS0.04 g  in 1 g
Inactive Ingredients
Ingredient NameStrength
ALLANTOIN (UNII: 344S277G0Z)  
ARACHIDYL ALCOHOL (UNII: 1QR1QRA9BU)  
ARNICA MONTANA FLOWER (UNII: OZ0E5Y15PZ)  
ASCORBIC ACID (UNII: PQ6CK8PD0R)  
DOCOSANOL (UNII: 9G1OE216XY)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7)  
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)  
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
DIPALMITOYL HYDROXYPROLINE (UNII: E6AHA53N1H)  
GLYCERIN (UNII: PDC6A3C0OX)  
SOYBEAN (UNII: L7HT8F1ZOD)  
SUNFLOWER OIL (UNII: 3W1JG795YI)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
PANTHENOL (UNII: WV9CM0O67Z)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
PROPYLPARABEN (UNII: Z8IX2SC1OH)  
WATER (UNII: 059QF0KO0R)  
SHEA BUTTER (UNII: K49155WL9Y)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:33261-788-0115 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH NOT FINALpart34810/01/2010
Labeler - Aidarex Pharmaceuticals LLC (801503249)

Revised: 1/2014
Document Id: 096a2ff6-e875-4d62-bad8-3afa55c8fede
Set id: 0a94abac-5e83-46bb-94e9-976375b49aa8
Version: 5
Effective Time: 20140128
 
Aidarex Pharmaceuticals LLC