Otc - Active Ingredient
Drug Facts
Active ingredient Purpose
Lidocaine HCI 4%...............................................................Topical anesthetic
Family Care Lidocaine Pain Relief Cream 1oz Cream
FDA Label NDC 65923-586
13 label sections · Submitted to the FDA by United Exchange Corp · Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by United Exchange Corp for the product Family Care Lidocaine Pain Relief Cream 1oz (NDC 65923-586). 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 - keep out of reach of children, otc - pregnancy or breast feeding, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Purpose
Use for the temporary relief of minor pain
Warnings
Warnings For external use only.
Otc - Do Not Use
Do not use
in large quantities
on large areas of the body or on cut, irritated or swollen skin
on puncture wounds
for more than one week without consulting a doctor
Otc - When Using
When using this product
use only as directed. Read and follow all directions and warnings on this
carton.
do not allow contact with the eyes and mucous membranes
do not bandage tightly or apply local heat (such as heating pads) or a
medicated patch to the area of use
do not use at the same time as other topical analgesics
Otc - Stop Use
Stop use and ask doctor if
condition persists or gets worse
redness is present
irritation develops
symptoms persist for more than 7 days or clear up and occur again
within a few days
Otc - Keep Out Of Reach Of Children
Keep out of reach of children. If swallowed, get medical help or contact a
Poison Control Center (1-800-222-1222) right away.
Otc - Pregnancy Or Breast Feeding
If pregnant or breast-feeding, ask a health professional before use.
Indications & Usage
Directions
push down and turn to open
adults and children 12 years of age and older:
apply a thin layer to the affected area every 6 to 8 hours, not to exceed 3
applications in a 24 hour period
children 12 years or younger: consult a doctor
Storage And Handling
Other information
store at room temperature 20-25°C (68-77°F)
Inactive Ingredient
Inactive ingredients
alcohol, aloe vera leaf, carbomer homopolymer, ceteth-20, cetostearyl
alcohol, dimethicone 350, edetate disodium, ethylhexylglycerin, glyceryl
stearate/PEG-100 stearate, methylparaben, purified water, trolamine
Dosage & Administration
Questions or comments?
Call 1-888-645-8204 Monday-Friday 9AM-5PM (PST)
Close cap tightly between uses.
*This product is not manufactured or distributed by Opella Healthcare Group,
distributor of Aspercreme® Pain Relief Cream with Lidocaine.
Distributed by: UNITED EXCHANGE CORP.
Cypress, CA 90630 USA | 1-888-645-8204
Made in China
684-ZDP-BX-R1
OM-TP-ZDP325-R1
Package Label.Principal Display Panel
684 (684)
* Please review the disclaimer below.
