Family Wellness Pain Relief With Lidocaine Cream
FDA Label NDC 55319-822

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Family Dollar (family Wellness) for the product Family Wellness Pain Relief With Lidocaine (NDC 55319-822). 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 drug facts, active, purpose, uses, warnings, do not use, when using this product, stop use and ask a doctor if, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

→ Drug Facts

→ Active

→ Purpose

→ Uses

→ Warnings

→ Do Not Use

→ When Using This Product

→ Stop Use And Ask A Doctor If

→ Keep Out Of Reach Of Children

→ Directions

→ Other Information

→ Inactive Ingredients

→ Questions ?

→ Principal Display Panel -tube

→ Principal Display Panel -carton

Drug Facts

Active

Lidocaine HCL 4%

Purpose

Topical anesthetic

Uses

Temporarily relieves minor pain

Warnings

For external use only

Do Not Use

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

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 or mucous membranes
do not bandage or apply local heat (such as heating pads) to the area of use.
do not use at the same time as other topcial analgesics

Stop Use And Ask A Doctor If

condition worsens
symptons persist for more than 7 days or clear up and occur again within a few days.
If pregnant or breast feeding, ask a health professional before use.
If pregnant or breast-feeding- ask a health professional before use.

Keep Out Of Reach Of Children

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

Directions

Adults and children over 12 years:
apply a thin layer to affected area every 6 to 8 hours, not to exceed 3 applications in a 24 hour period
Children under 12 years or younger: ask a doctor

Other Information

Store at controlled room temperature 20°-25°C (68°-77°F)

Inactive Ingredients

Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Aloe Barbadensis Leaf Juice, Aminomethyl Propanol, C30-45 Alkyl Cetearyl Dimethicone Crosspolymer, Caprylyl Methicone, Cetearyl Alcohol, Ceteth-20 Phosphate, Dicetyl Phosphate, Dimethicone, Disodium EDTA, Ethylhexylglycerin, Glyceryl Stearate, Phenoxyethanol, SD Alcohol 40, Steareth-21, Water (purified)