LIDOCAINE PAIN RELIEF ROLL-ON- lidocaine 4% liquid 
Humco Holding Group, Inc.

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Private Label Lidocaine 4% Roll-On

Adults and children 2 years of age and older: apply to the affected area no more than 3 to 4 times daily.

Children under 2 years of age: consult a doctor.

acrylates/C10-30 alkyl acrylate crosspolymer, aloe barbadensis leaf juice, aminomethyl propanol, C30-45 alkyl cetearyl dimethicone crosspolymer, caprylyl methicone, cetearyl alcohol, ceteth-20 phosphate, dicetyl phosphate, dimethicone, disodium EDTA, ethylhexylglycerin, glyceryl stearate, hydroxyethyl acrylate/sodium acryloyldimethyl taurate copolymer, methylparaben, polysorbate 60, SD alcohol 40 (15%), steareth-2, steareth-21, water

Lidocaine 4%

For External Use Only.

When using this product:

use only as directed

do not bandage tightly or use with a heating pad

avoid contact with eyes

do not apply to wounds or damaged skin

do not use in large quantities

partifcularly over raw surfaces or blistered areas

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

For temporarily relief of pain and itching.

Topical analgesic

CVS Label

CVS Lidocaine CartonCVGSLido.jpglido

Equate Label

EQLido.jpg

LIDOCAINE PAIN RELIEF ROLL-ON 
lidocaine 4% liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0395-9130
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
LIDOCAINE HYDROCHLORIDE (UNII: V13007Z41A) (LIDOCAINE - UNII:98PI200987) LIDOCAINE HYDROCHLORIDE ANHYDROUS4 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
AMINOMETHYLPROPANOL (UNII: LU49E6626Q)  
WATER (UNII: 059QF0KO0R)  
STEARETH-21 (UNII: 53J3F32P58)  
ALCOHOL (UNII: 3K9958V90M)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
CAPRYLYL TRISILOXANE (UNII: Q95M2P1KJL)  
CARBOMER INTERPOLYMER TYPE A (55000 CPS) (UNII: 59TL3WG5CO)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)  
DIHEXADECYL PHOSPHATE (UNII: 2V6E5WN99N)  
CETETH-20 PHOSPHATE (UNII: 921FTA1500)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
HYDROXYETHYL ACRYLATE/SODIUM ACRYLOYLDIMETHYL TAURATE COPOLYMER (45000 MPA.S AT 1%) (UNII: 86FQE96TZ4)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0395-9130-971 in 1 CARTON06/05/2019
174 mL in 1 BOTTLE, WITH APPLICATOR; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM01706/05/2019
Labeler - Humco Holding Group, Inc. (825672884)
Registrant - Pharma Nobis, LLC (118564114)
Establishment
NameAddressID/FEIBusiness Operations
Pharma Nobis, LLC118564114manufacture(0395-9130) , analysis(0395-9130) , label(0395-9130) , pack(0395-9130)

Revised: 12/2023
Document Id: 0c9380d5-c285-0902-e063-6394a90ac157
Set id: a8be9e46-1616-40a9-e053-2a95a90ac3bc
Version: 4
Effective Time: 20231215
 
Humco Holding Group, Inc.