Other
SOUNDBODY
LIDOCAINE
PAIN RELIEVING CREAM
Drug Facts
Lidocaine Creme
FDA Label NDC 67510-0680
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Kareway Product, Inc. for the product Lidocaine Creme (NDC 67510-0680). 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 other, active ingredients, purposes, 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
Active Ingredients
Lidocaine HCl 4%
Purposes
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 label
- rare cases of serious burns have been reported with products of this type
- do not bandage tightly or apply local heat (such as heating pads) to the area of use or use with a medicated patch
- avoid contact with eyes and mucous membranes
- a transient burning sensation may occur upon application but generally disappears in several days
Stop Use And Ask A Doctor If
- condition worsens
- redness is present
- irritation develops
- symptoms persist for more than 7 days or clear up and occur again within a few days
- you experience signs of skin injury, such as pain, swelling, or blistering where the product was applied
If Pregnant Or Breast-Feeding,
ask a health professional before use.
Keep Out Of Reach Of Children And Pets.
If swallowed, get medical help or contact a 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
- AFTER APPLYING, WASH HANDS WITH SOAP AND WATER
children 12 years or younger: ask a doctor
Inactive Ingredients
acrylates/C10-30 alkyl acrylate crosspolymer, aloe barbadensis leaf juice, aminomethyl propanol, cetearyl alcohol(and)dicetyl phosphate(and)ceteth-10 phosphate, cyclopentasiloxane, dimethicone, dimethicone/vinyl dimethicone crosspolymer, disodium EDTA, ethylhexylglycerin, glyceryl stearate, hydroxyethyl acrylate / sodium acryloyldimethyl taurate copolymer, isohexadecane, phenoxyethanol, SD alcohol 40 (15%), steareth-21, water
Principal Display Panel
SOUNDBODY
Lidocaine
Plus Menthol
Pain Relieving Cream
Carton (0680 Mxstrgpainrelvcreamlidocn0.75oz)
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