CBD4 FREEZE PUMP VANISHING SCENT- 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

When using this product

Stop use and ask a doctor if

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:

Children 12 years or younger: ask a doctor

Other information

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.

PRODUCT LABEL

image description

CBD4 FREEZE PUMP VANISHING SCENT 
lidocaine, menthol cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:80875-421
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
LIDOCAINE (UNII: 98PI200987) (LIDOCAINE - UNII:98PI200987) LIDOCAINE4 g  in 100 g
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL1 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
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)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:80875-421-6060 g in 1 TUBE; Type 0: Not a Combination Product10/29/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34810/29/2020
Labeler - HMP BRANDS, LLC (117688328)
Establishment
NameAddressID/FEIBusiness Operations
HMP BRANDS, LLC117688328manufacture(80875-421)

Revised: 10/2020
Document Id: fa4214b0-f0d6-43b4-a306-d276f8afc5c6
Set id: 507740f3-17d5-4acd-814e-75f5dcb372a0
Version: 1
Effective Time: 20201022
 
HMP BRANDS, LLC