CBD4 pain relief cream by HMP BRANDS, LLC

Drug Details [pdf]

CBD4 PAIN RELIEF CREAM- lidocaine, menthol cream
HMP 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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Active Ingredient Purpose

Lidocaine HCI USP 4%.............................. Topical anesthetic

Menthol USP 1 % .................................... Topical analgesic

Use

Temporarily relieves minor pain.

Warnings

For external use only.

Do not use

on large areas of the body 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 label
Rare cases of serious burns have been reported with products of this type
Do not bandage tightly or apply local heat (such as heating pads) to the area of use or use with a medicated patch
Avoid contact with eyes and mucous membranes
A transient burning sensation may occur upon application but generally disappears in several days

Stop use and ask a doctor if

condition worsens
redness is present
irritation develops
symptoms persist for more than 7 days or clear up and occur again within a few days
You experience signs of skin injury, such as pain, swelling, or blistering where the product was applied

If pregnant or breast-feeding, ask a healthcare professional before use.

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Directions

adults and children over 12 years:

Apply a thin layer to affected area every 6 to 8 hours, not to exceed 3 applications in a 24 hour period.
After applying, wash hands with soap and water

Children 12 years or younger: ask a doctor

Other information

Store between 15-30C (59-86F)
Avoid freezing and excessive heat above 40C (104F)

Inactive ingredients

cetostearyl alcohol, citric acid, hemp extract(cannabidiol), light liquid paraffin, macrogol cetostearyl ether, methyl parahydroxybenzoate, peppermint oil, purified water, sodium citrate and white soft paraffin.

Other information

Store at 68-77F (20-25C) in a dry place.
Keep from freezing.

Package Label - Principal Display Panel

image description

CBD4 PAIN RELIEF CREAM
lidocaine, menthol cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 80875-420
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
LIDOCAINE (UNII: 98PI200987) (LIDOCAINE - UNII:98PI200987)	LIDOCAINE	4 g in 100 g
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL	1 g in 100 g

Ingredient Name	Strength
Inactive Ingredients
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
CANNABIDIOL (UNII: 19GBJ60SN5)
LIGHT MINERAL OIL (UNII: N6K5787QVP)
POLYOXYL 20 CETOSTEARYL ETHER (UNII: YRC528SWUY)
METHYLPARABEN (UNII: A2I8C7HI9T)
PEPPERMINT OIL (UNII: AV092KU4JH)
WATER (UNII: 059QF0KO0R)
SODIUM CITRATE (UNII: 1Q73Q2JULR)
PETROLATUM (UNII: 4T6H12BN9U)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC: 80875-420-60	60 g in 1 TUBE; Type 0: Not a Combination Product	10/22/2020	10/22/2020

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part348	10/22/2020	10/22/2020

Labeler - HMP BRANDS, LLC (117688328)

Name	Address	ID/FEI	Business Operations
Establishment
HMP BRANDS, LLC		117688328	manufacture(80875-420)

Revised: 8/2022

Document Id: e531caae-f722-5ab9-e053-2995a90a93a0

Set id: bac134e2-3c1e-446a-acbf-f7dbb3b69f9c

Version: 2

Effective Time: 20220801