BEAUELI- lidocaine cream 
EUbizrival 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 ingredients

Lidocaine 5%

Purpose

Local Anesthetic

Uses

For the temporary relief of local and anorectal itching and discomfort associated with anorectal disorders.

Warnings

For external use only

When using this product

Stop use and ask a doctor if

Keep out of reach of children.If swallowed, get medical help. Do not use if allergic to any ingredients.

If pregnant or breastfeedingask a health professional before use.

Directions

Other information

Store at room temperature. Avoid direct sunlight. Do not use if temper evident packaging has been breached or is missing.

water, glycerine, Lidocaine Lsopropyl palmitate, Aloe barbadensis leaf juice, Retinol,Helianthus annuus (sunflower)seed oil, Glyceryl stearate,
Pentylene glycol, Butyrospermum parkii (shea)butter,Cetyl alcohol, Piper methysticum leaf/root/stem extract, Peg-100 stearate, Tocopheryl acetate.

Product label

image description

BEAUELI 
lidocaine cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:83462-001
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
LIDOCAINE (UNII: 98PI200987) (LIDOCAINE - UNII:98PI200987) LIDOCAINE5 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
GLYCERIN (UNII: PDC6A3C0OX)  
ALOE (UNII: V5VD430YW9)  
SHEA BUTTER (UNII: K49155WL9Y)  
RETINOL (UNII: G2SH0XKK91)  
SUNFLOWER OIL (UNII: 3W1JG795YI)  
GLYCERYL STEARATE SE (UNII: FCZ5MH785I)  
PENTYLENE GLYCOL (UNII: 50C1307PZG)  
CETYL ALCOHOL (UNII: 936JST6JCN)  
PIPER METHYSTICUM WHOLE (UNII: 3P306S300W)  
PEG-100 STEARATE (UNII: YD01N1999R)  
.ALPHA.-TOCOPHEROL ACETATE, D- (UNII: A7E6112E4N)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:83462-001-0150 g in 1 BOTTLE; Type 0: Not a Combination Product07/01/2023
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34807/01/2023
Labeler - EUbizrival LLC (036572203)
Establishment
NameAddressID/FEIBusiness Operations
Guangzhou Pallas Cosmetics Co.,Ltd.419564106manufacture(83462-001)

Revised: 8/2023
Document Id: 03339501-199f-81bc-e063-6294a90aac3e
Set id: f725ecd1-96de-4f9f-94c9-d22c676285b2
Version: 1
Effective Time: 20230818
 
EUbizrival LLC