Label: CVS HEALTH LIDOCAINE PAIN-RELIEVING- lidocaine patch
- NDC Code(s): 66902-276-06
- Packager: Natural Essentials, 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 October 13, 2022
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- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- Active ingredients
- Purpose
- Use
-
Warnings
For external use only
Do not use
- more than 1 patch on your body at a time 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 use more than one patch in an 8 hour period. Maximum 3 patches per day.
- Rare cases of serious burns have been reported with products of this type
- Do not apply to wounds or damaged, broken or irritated skin
- Do not allow contact with the eyes and mucous membranes
- 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 products that can produce serious adverse effects if a child or pet chews or ingests this patch
- NOTE: patches may not adhere as well to all individuals, skin types, or certain parts of the body.
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Directions
- Adults/children 12 years and older
- clean and dry affected area
- remove backing from patch by firmly grasping both ends and gently pulling until backing separates in middle
- carefully remove smaller portion of backing from patch and apply exposed portion of patch to affected area
- once exposed portion of patch is positioned, carefully remove remaining backing completely to apply patch to affected area
- once applied, press firmly and rub on all sides and center of patch to help adhesive adhere to skin
- do not remove patch and reapply, this will result in the patch not sticking
- avoid strenuous exercise while wearing patch, this will result in patch not sticking
- do not use more than one patch in an 8 hour period.
- Other information
- Inactive ingredients
-
Principal Display Panel – 567 mg Carton Label
CVS
Health™Compare to the active
ingredient in Salonpas®
4% Lidocaine Gel Patch*MAXIMUM STRENGTH
Lidocaine concentration
without a prescription†Lidocaine
Pain-Relieving
PatchLIDOCAINE 4% GEL
Numbing muscle
& joint reliefFor temporary relief of
minor aches & pains:- Arthritis
- Bruises
- Strains & sprains
Unscented
6 PATCHES
3 15/16" x 5 1/2" (10 cm x 14 cm)
†Among over the counter
topical analgesics. -
Principal Display Panel – 567 mg Vial Label
CVS
Health™MAXIMUM STRENGTH
Lidocaine concentration
without a prescription†Lidocaine
Pain-Relieving
PatchLIDOCAINE 4% GEL
Numbing muscle & joint relief
For temporary relief of
minor aches & pains:- Arthritis
- Bruises
- Strains & sprains
Unscented
1 PATCH
3 15/16" x 5 1/2"
(10 cm x 14 cm)†Among over the counter
topical analgesics. -
INGREDIENTS AND APPEARANCE
CVS HEALTH LIDOCAINE PAIN-RELIEVING
lidocaine patchProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:66902-276 Route of Administration TRANSDERMAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Lidocaine (UNII: 98PI200987) (Lidocaine - UNII:98PI200987) Lidocaine 567 mg Inactive Ingredients Ingredient Name Strength DIHYDROXYALUMINUM AMINOACETATE ANHYDROUS (UNII: 1K713C615K) GLYCERIN (UNII: PDC6A3C0OX) KAOLIN (UNII: 24H4NWX5CO) METHYLPARABEN (UNII: A2I8C7HI9T) POLYACRYLIC ACID (8000 MW) (UNII: 73861X4K5F) POLYSORBATE 80 (UNII: 6OZP39ZG8H) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) PROPYLPARABEN (UNII: Z8IX2SC1OH) POVIDONE K90 (UNII: RDH86HJV5Z) SODIUM POLYACRYLATE (8000 MW) (UNII: 285CYO341L) TARTARIC ACID (UNII: W4888I119H) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) WATER (UNII: 059QF0KO0R) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:66902-276-06 6 in 1 BOX 12/18/2019 1 1 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 12/18/2019 Labeler - Natural Essentials, Inc. (947484713) Establishment Name Address ID/FEI Business Operations Foshan Aqua Gel Biotech Co., Ltd. 529128763 MANUFACTURE(66902-276)
