PURE CBD HYDROGEL XL WITH LIDOCAINE 4%- lidocaine 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

PURE CBD HYDROGEL XL PATCH WITH LIDOCAINELidocaine 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

Lidocaine 4%

Purpose

Topical Anesthetic

Uses

Temporarily relieves pain and itching associated with:

• minor burns

• sunburn

• minor cuts

• scrapes

• insect bites

• minor skin irritations

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.

Keep out of reach of children and pets.

If swallowed, get medical help or contact a Poison Control Center immediately.

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

Store at room temperature 15°-30°C (59°-86°F)

Avoid storing product in direct sunlight and protect product from excessive moisture.

Inactive ingredients

CBD (Hemp Extract), Dihydroxyaluminium Aminoacetate, Disodium Edetate, Gelatin, Glycerin, Kaolin, Methylparaben, Polyacrylic Acid, Polyvinyl Alcohol, Propylene Glycol, Propylparaben, Sodium Carboxymethylcellulose, Sodium Polyacrylate, Sorbitol, Tartaric Acid, Urea and Purified Water.

PRINCIPAL DISPLAY PANEL

Pure CBD Hydrogel XL Patch with Lidocaine 4%

NDC 71436-3004-5

5 Patches

Ari Brands, LLC

PRINCIPAL DISPLAY PANEL

Pure CBD Hydrogel XL Patch with Lidocaine 4%
NDC 71436-3004-5
5 Patches 

Ari Brands, LLC

PURE CBD HYDROGEL XL  WITH LIDOCAINE 4%
lidocaine patch
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71436-3004
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
LIDOCAINE (UNII: 98PI200987) (LIDOCAINE - UNII:98PI200987) LIDOCAINE40 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:71436-3004-55 in 1 CARTON01/15/2020
115 g in 1 PATCH; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH NOT FINALpart34801/15/2020
Labeler - ARI BRANDS, LLC (080658382)
Establishment
NameAddressID/FEIBusiness Operations
USpharma Ltd080664601MANUFACTURE(71436-3004)

Revised: 1/2020
Document Id: 523eab0f-13e8-4d1e-b3d5-63ca79ba8ab9
Set id: f502269b-3944-49c4-83b0-8c4ecafeaf50
Version: 2
Effective Time: 20200123
 
ARI BRANDS, LLC