Label: PRO COMFORT 8 HOURS PATCH- lidocaine patch 4% patch
- NDC Code(s): 83568-4643-1, 83568-4643-5
- Packager: CARE LIVING DIAGNOSTICS INC
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph not final
DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.
Drug Label Information
Updated July 29, 2023
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
-
Product Information
Active Ingredient
Lidocaine 4% . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Purpose
Topical Anesthetic
Uses
for the temporary relief of pain
Warnings
For external use only
Do not use
- more than 1 patch on your body at a time
- on puncture wounds,
- on cuts, irritated or swollen skin
- 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
- do not bandage tightly or apply local heat (such as heating pads) to the area of use
- do not use at the same time as other topical analgesics
- dispose of used patch in manner that always keeps product away from children and pets. Used patches still contain the drug product that can produce serious adverse effects if a child or pet chews or ingests this patch
Stop use and ask a doctor if
- condition worsens
- symptoms persist for more than 7 days or clear up and occur again within a few days
- redness or irritation develops
- 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 (1-800-222-1222).
Directions
Adults and children over 12 years:
- wish and dry affected area
- Peel off the backing fim from one side of the patch carefully
- Apply the exposed portion of the patch to the affected area
- Gently press the patch with your hand to fit the affected area completely
- Do not exercise vigorously during use to prevent the patch from falling off
- use only 1 patch for a maximum of 8 hours
children under 12 years of age: Ask a doctor before use
Other Information
store at room temperature 15°-30°C (59°-86°F).
Inactive ingredients
aluminum glycinate, glycerin, methyl acrylate, polyacrylic acid, polysorbate 80, propylene glycol, sodium polyacrylate, tartaric acid, poval, alcohol, water
Questions or Comments?
E-mail: info@carelivingusa.com
Child-Resistant Packaging
Manufactured forCARE LIVING DIAGNOSTICS INC.
Www.carelivingusa.com
Made in China
- Active Ingredient
- Purpose
- Uses
- Warnings
- Do not use
-
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
- do not bandage tightly or apply local heat (such as heating pads) to the area of use
- do not use at the same time as other topical analgesics
- dispose of used patch in manner that always keeps product away from children and pets.
- Used patches still contain the drug product that can produce serious adverse effects if a child or pet chews or ingests this patch
- Stop use and ask a doctor if
- If pregnant or breast-feeding,
- Keep out of reach of children and pets.
-
Directions
Adults and children 12 years of age and older:
- Wash and dry the affected area.
- Peel off the backing film from one side of the patch carefully.
- Apply the exposed portion of the patch to the affected area.
- Gently press the patch with your hand to fit the affected area completely.
- Do not exercise vigorously during use to prevent the patch from falling off.
- Ues only 1 patch for a maximum of 8 hours.
children under 12 years of age:Ask a doctor before use.
- Other Information
- Inactive ingredients
- Questions or Comments?
- Manufactured for:
- Dosage
- PRINCIPAL DISPLAY PANEL
- Pro Comfort 8 Hour Lidocaine Patch
-
INGREDIENTS AND APPEARANCE
PRO COMFORT 8 HOURS PATCH
lidocaine patch 4% patchProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:83568-4643 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength LIDOCAINE (UNII: 98PI200987) (LIDOCAINE - UNII:98PI200987) LIDOCAINE 4 g in 100 g Inactive Ingredients Ingredient Name Strength DIHYDROXYALUMINUM AMINOACETATE ANHYDROUS (UNII: 1K713C615K) GLYCERIN (UNII: PDC6A3C0OX) POLYACRYLIC ACID (8000 MW) (UNII: 73861X4K5F) POLYSORBATE 80 (UNII: 6OZP39ZG8H) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) SODIUM POLYACRYLATE (8000 MW) (UNII: 285CYO341L) TARTARIC ACID (UNII: W4888I119H) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) UREA (UNII: 8W8T17847W) ALCOHOL (UNII: 3K9958V90M) WATER (UNII: 059QF0KO0R) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:83568-4643-5 5 in 1 BOX 08/01/2023 1 NDC:83568-4643-1 4 g in 1 PATCH; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part348 08/01/2023 Labeler - CARE LIVING DIAGNOSTICS INC (125354643)