WESTERN FAMILY ANTIBIOTIC PLUS PAIN RELIEF- neomycin sulfate, polymyxin b sulfate, and pramoxine hydrochloride cream

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

Neomycin sulfate (UNII: 057Y626693) (Neomycin - UNII:I16QD7X297), Polymyxin B sulfate (UNII: 19371312D4) (Polymyxin B - UNII:J2VZ07J96K), Pramoxine hydrochloride (UNII: 88AYB867L5) (Pramoxine - UNII:068X84E056)

Available from:

Western Family Foods Inc

INN (International Name):

Neomycin sulfate

Composition:

Neomycin 3.5 mg in 1 g

Administration route:

TOPICAL

Prescription type:

OTC DRUG

Therapeutic indications:

first aid to help prevent infection and for the temporary relief of pain or discomfort in - minor cuts - scrapes - burns

Authorization status:

OTC monograph final

Summary of Product characteristics

WESTERN FAMILY ANTIBIOTIC PLUS PAIN RELIEF- NEOMYCIN SULFATE,
POLYMYXIN B
SULFATE, AND PRAMOXINE HYDROCHLORIDE CREAM
WESTERN FAMILY FOODS 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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WESTERN FAMILY
ANTIBIOTIC PLUS PAIN RELIEF
_DRUG FACTS_
_ACTIVE INGREDIENTS (EACH GRAM_
_CONTAINS)_
_PURPOSE_
Neomycin sulfate 3.5 mg
First aid antibiotic
Polymyxin B sulfate 10,000 units
First aid antibiotic
Pramoxine hydrochloride 10 mg
Topical analgesic
US ES
first aid to help prevent infection and for the temporary relief of
pain or discomfort 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 1 week
ASK A DOCTOR BEFORE USE
on deep or puncture wounds, animal bites, or serious burns
STOP USE AND ASK A DOCTOR IF
condition gets worse
condition persists for more than 7 days
condition clears up and occurs again within a few days
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
Adults and children 2 years of age and older:
clean the affected area and dry thoroughly
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
Children under 2 years of age: consult a doctor
OTHER INFORMATION
store at controlled room temperature
see carton or tube crimp for lot number and expiration date
INACTIVE INGREDIENTS
emulsifying wax, methylparaben, mineral oil, propylene glycol,
purified water, white petrolatum
QUES TIONS ?
Call 1-866-923-4914
Distributed By:
WESTERN FAMILY FOODS, INC.
P.O. Box 4057, Portland, OR 97208
PRINCIPAL DISPLAY PANEL - 14.2 G TUBE CARTON
_ANTIBIOTIC_
_CREAM + PAIN RELIEF_
(Neomycin Sulfate
Polymyxin B Sulfate-Pra