CARE ONE MAXIMUM STRENGTH FIRST AID ANTIBIOTIC- neomycin sulfate polymyxin b sulfate pramoxine hydrochloride cream

Care One Maximum Strength First Aid Antibiotic by

Drug Labeling and Warnings

Care One Maximum Strength First Aid Antibiotic by is a Otc medication manufactured, distributed, or labeled by Foodhold U.S.A. LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active ingredients (in each gram) Purpose

Neomycin Sulfate 3.5 mg............................................................ First aid antibiotic

Polymyxin B Sulfate 10,000 units................................................ First aid antibiotic

Pramoxine HCl10 mg.................................................................. External analgesic

PURPOSE

Uses

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

WARNINGS

Warnings

For external use only

DO NOT USE

Do not use

• if you are allergic to any of the ingredients
• in the eyes or nose
• over large areas of the body

ASK DOCTOR

Ask a doctor before use if you have

• deep or puncture wounds
• animal bites
• serious burns

STOP USE

Stop use and ask a doctor if

• you need to use longer than 1 week
• rash or allergic reaction develops
• symptoms persist for more than 1 week or clear up and come back within a few days
• condition persists or gets worse
• redness, irritation, swelling, or pain persists or increases

PREGNANCY OR BREAST FEEDING

If pregnant or breast-feeding, ask a health professional before use

KEEP OUT OF REACH OF CHILDREN

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

INDICATIONS & USAGE

Directions

Adult and children 2 years of age and older

• clean affected area
• apply a small amount (equal to surface area of the tip of the finger) on area 1 to 3 times daily
• may be covered with a sterile bandage
• Children under 2 years: ask a doctor

STORAGE AND HANDLING

Other information

• Store at room temperature

INACTIVE INGREDIENT

Inactive ingredients

cetyl alcohol, methylparaben, mineral oil, petrolatum, polysorbate 60, propylene glycol, propylparaben, purified water, sorbitan monostearate, stearic acid

DOSAGE & ADMINISTRATION

DISTRIBUTED BY

FOODHOLD, U.S.A., LLC

LANDOVER, MD 20785

MADE IN SOUTH KOREA

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

CARE ONE MAXIMUM STRENGTH FIRST AID ANTIBIOTIC 
neomycin sulfate polymyxin b sulfate pramoxine hydrochloride cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 41520-315
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
NEOMYCIN SULFATE (UNII: 057Y626693) (NEOMYCIN - UNII:I16QD7X297)	NEOMYCIN	3.5 mg  in 1 g
PRAMOXINE HYDROCHLORIDE (UNII: 88AYB867L5) (PRAMOXINE - UNII:068X84E056)	PRAMOXINE HYDROCHLORIDE	10 mg  in 1 g
POLYMYXIN B SULFATE (UNII: 19371312D4) (POLYMYXIN B - UNII:J2VZ07J96K)	POLYMYXIN B	10000 [USP'U]  in 1 g

Inactive Ingredients
Ingredient Name	Strength
CETYL ALCOHOL (UNII: 936JST6JCN)
METHYLPARABEN (UNII: A2I8C7HI9T)
MINERAL OIL (UNII: T5L8T28FGP)
PETROLATUM (UNII: 4T6H12BN9U)
POLYSORBATE 60 (UNII: CAL22UVI4M)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
SORBITAN MONOSTEARATE (UNII: NVZ4I0H58X)
STEARIC ACID (UNII: 4ELV7Z65AP)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 41520-315-14	1 in 1 BOX	02/02/2019
1		14 g in 1 TUBE; 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	09/08/2014

Labeler - Foodhold U.S.A. LLC (809183973)