Label: PURE CBD HYDROGEL XL WITH LIDOCAINE 4%- lidocaine patch
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Contains inactivated NDC Code(s)
NDC Code(s): 71436-3004-5 - Packager: ARI BRANDS, LLC
- 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 January 23, 2020
If you are a consumer or patient please visit this version.
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- Official Label (Printer Friendly)
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SPL UNCLASSIFIED SECTION
PURE CBD HYDROGEL XL PATCH WITH LIDOCAINE – Lidocaine 4% Patch
Ari Brands, LLC
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.
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Pure CBD Hydrogel XL Patch with Lidocaine 4%
Drug Facts
- Active ingredient
- Purpose
- Uses
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Warnings
For external use only.
Do not use
• More than one patch at a time or on irritated or swollen skin
• On wounds, damaged, or infected skin
• On eyes, mouth, genitals or other mucous membranes
• With a heating pad
• If you are allergic to any ingredients of this product
Allergy Alert: if you are allergic to any inactive ingredient of this product, contact a doctor before use.
When using this product
• Use only as directed. Read and follow all directions and warnings on the carton and packet insert before use.
• Avoid contact with eyes, mucous membranes, or rashes.
• 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 or anesthetics.
• Dispose of used patch in a 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 consult a physician:
• If pregnant or breast feeding
• If localized skin reactions occur, such as rash, itching, redness, irritation, pain, swelling, and blistering
• If condition worsens, or if symptoms persist for more than 7 days or clear up and occur again within a few days, discontinue use of this product and consult a physician.
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Directions
Adults and children 12 years of age and older:
Apply 1 patch to the affected area of intact skin up to 12 hours.
- Clean and dry the affected area.
- Open pouch and remove one patch.
- Remove any protective film and apply directly to affected area of pain. Apply immediately after removal from the protective envelope.
- Wash hands with soap and water after handling the patches.
- Reseal pouch containing unused patches after each use. Do not store patch outside the sealed envelope.
- Fold used patches so that the adhesive side sticks to itself and safely discard used patches or pieces of cut patches where children and pets cannot get to them.
Children under 12 years: Ask a physician
- Other information
- Inactive ingredients
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
PURE CBD HYDROGEL XL WITH LIDOCAINE 4%
lidocaine patchProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:71436-3004 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength LIDOCAINE (UNII: 98PI200987) (LIDOCAINE - UNII:98PI200987) LIDOCAINE 40 mg in 1 g Inactive Ingredients Ingredient Name Strength POLYACRYLIC ACID (8000 MW) (UNII: 73861X4K5F) HEMP (UNII: TD1MUT01Q7) DIHYDROXYALUMINUM AMINOACETATE (UNII: DO250MG0W6) EDETATE DISODIUM (UNII: 7FLD91C86K) GELATIN (UNII: 2G86QN327L) GLYCERIN (UNII: PDC6A3C0OX) KAOLIN (UNII: 24H4NWX5CO) METHYLPARABEN (UNII: A2I8C7HI9T) POLYACRYLIC ACID (450000 MW) (UNII: KD3S7H73D3) POLYVINYL ALCOHOL, UNSPECIFIED (UNII: 532B59J990) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) PROPYLPARABEN (UNII: Z8IX2SC1OH) CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM (UNII: K679OBS311) SODIUM POLYACRYLATE (2500000 MW) (UNII: 05I15JNI2J) TARTARIC ACID (UNII: W4888I119H) UREA (UNII: 8W8T17847W) WATER (UNII: 059QF0KO0R) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:71436-3004-5 5 in 1 CARTON 01/15/2020 1 15 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 01/15/2020 Labeler - ARI BRANDS, LLC (080658382) Establishment Name Address ID/FEI Business Operations USpharma Ltd 080664601 MANUFACTURE(71436-3004)
