Label: SOUNDBODY- lidocaine, menthol patch
- NDC Code(s): 67510-0636-1
- Packager: Kareway Product, 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 May 18, 2018
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- Official Label (Printer Friendly)
- Active ingredient
- Purposes
- Uses
- Warnings
- Do Not Use
-
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 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 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
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Directions
adults and children over 12 years:
- 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 to completely apply patch to affected area
- use 2 patch for up to 24 hours
children 12 years or younger: ask a doctor
- Inactive Ingredients
-
Package/Label Principal Display Panel
Pure-Aid
MAXIMUM STRENGTH
LIDOCAINE PATCH
PLUS MENTHOLTargeted Immediate Pain Relief
- Desensitizes Aggravated Nerves
- Dual Action with Lidocaine and Menthol
- Fast Acting and Long Lasting
- First Aid for Pain
Pain Relieving Ointment
on a Breathable Adhesive PadContains 1 Patch
3-15/16” x 5-1/2” (10 cm x 14 cm) eachLabel
-
INGREDIENTS AND APPEARANCE
SOUNDBODY
lidocaine, menthol patchProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:67510-0636 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength LIDOCAINE (UNII: 98PI200987) (LIDOCAINE - UNII:98PI200987) LIDOCAINE 40 mg MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL 10 mg Inactive Ingredients Ingredient Name Strength DIHYDROXYALUMINUM AMINOACETATE (UNII: DO250MG0W6) GLYCERIN (UNII: PDC6A3C0OX) METHYLPARABEN (UNII: A2I8C7HI9T) KAOLIN (UNII: 24H4NWX5CO) PROPYLPARABEN (UNII: Z8IX2SC1OH) POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ) TARTARIC ACID (UNII: W4888I119H) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) WATER (UNII: 059QF0KO0R) POLYACRYLIC ACID (8000 MW) (UNII: 73861X4K5F) SODIUM POLYACRYLATE (8000 MW) (UNII: 285CYO341L) POLYSORBATE 80 (UNII: 6OZP39ZG8H) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:67510-0636-1 1 in 1 POUCH; Type 0: Not a Combination Product 05/18/2018 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part348 03/02/2018 Labeler - Kareway Product, Inc. (121840057)