PROCOMYCIN- bacitracin, neomycin, polymyxin b and lidocain hydrochloride cream 
Physicians Science & Nature Inc.

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

First aid to help prevent the infection in minor cuts, scrapes and burns
For the temporary relief of pain or itching.

Warnings

For external use only.

Do not use

in the eyes
over large areas of the body
if allergic to any of the ingredients
longer than 1 week unless directed by a doctor.

Consult a doctor

if under 2 years of age
in case of deep cuts or puncture wounds, animal or human bites, or serious burns
if pregnant or breast feeding.

Stop use and consult a doctor

if the condition persists or worsens
if symptoms persist for more than 7 days or clear up and occur again within a few days
if a rash or other allergic reaction develops.

Keep out of reach of children.

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

Directions for use

Clean the affected area
apply a small amount of this product (an amount equal to the surface area of the tip of the finger) on the area 3 times daily.
may be covered with a sterile bandage
store at controlled room temperature 15°-30° (59°-86°).

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

Package/Label Principal Display Panel

Label

Label

PROCOMYCIN 
bacitracin, neomycin, polymyxin b and lidocain hydrochloride cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)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 HYDROCHLORIDE0.04 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:27495-010-0115 g in 1 TUBE; Type 0: Not a Combination Product10/01/201001/01/2017
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34510/01/201001/01/2017
Labeler - Physicians Science & Nature Inc. (012485755)
Establishment
NameAddressID/FEIBusiness Operations
Westwood Laboratories069926483MANUFACTURE(27495-010)

Revised: 2/2019
 
Physicians Science & Nature Inc.