The following Structured Product Label (SPL) was submitted to the FDA by United Exchange Corp for the product Family Care Antibiotic Pain Relief 0.33oz (NDC 65923-578). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding otc - active ingredient, otc - purpose, warnings, otc - do not use, otc - when using, otc - stop use, otc - pregnancy or breast feeding, otc - keep out of reach of children, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Active ingredients (in each gram) Purposes
Neomycin Sulfate (3.5 mg).......................................................First Aid Antibiotic
Polymyxin B Sulfate (10,000 units)...........................................First Aid Antibiotic
Pramoxine HCI (10 mg)............................................................External Analgesic
Uses
first aid to help prevent infection and for the temporary relief of pain 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
Ask a doctor before use if you have
deep or puncture wounds
animal bites
serious burns
Stop use and ask a doctor if
condition persists or gets worse
rash or other allergic reaction develops
you need to use longer than 1 week
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 (1-800-222-1222) right away.
Directions
adults and children 2 years of age and older:
clean the affected area
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 2 years or younger: consult with a doctor
Other information
store at 20° to 25°C (68° to 77°F)
Inactive ingredients
butylated hydroxytoluene, cetyl alcohol, light mineral oil, methylparaben,
petrolatum, polysorbate 60, propylene glycol, propylparaben, purified water,
sorbitan monostearate, stearic acid
Questions or comments?
Call 1-888-645-8204 Monday-Friday 9AM-5PM (PST)
*This product is not manufactured or distributed by Kenvue Brands LLC
distributor of Neosporin® + Pain Relief Cream.
Distributed by: UNITED EXCHANGE CORP.
Cypress, CA 90630 USA | 1-888-645-8204
Made in China
689-ZDP-BX-R1
OM-TP-ZDP311-R1
* Please review the disclaimer below.
