PAIN RELIEF ROLL-ON- lidocaine 4% liquid 
Bionpharma Inc.

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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pain relief roll-on

Active ingredient

Lidocaine 4%

Purpose

Topical analgesic

Uses

For temporarily relief of pain and itching.

Warnings

For external use only.

When using this product

  • use only as directed
  • do not bandage tightly
  • avoid contact with eyes
  • do not apply to wounds or damaged skin
  • do not use in large quantities, particularly over raw surfaces or blistered areas

Stop use and ask a doctor

If

  • condition worsens
  • symptoms persist for more than 7 days or clear up and occur again within a few days

Keep out of reach of children.

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

Directions

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.

Inactive ingredients

Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Aloe Barbadensis Leaf Extract, Aminomethyl Propanol, C30-45 Alkyl Cetearyl Dimethicone Crosspolymer, Caprylyl Methicone, Cetearyl Alcohol, Ceteth-20 Phosphate, Dicetyl Phosphate, Dimethicone, Disodium EDTA, Ethylhexylglycerin, Glyceryl Stearate, Methylparaben, polysorbate 60, SD Alcohol 40, Steareth-21, Purified Water

Carton Label

*compare to the active ingredient

in Aspercreme® Odor Free

with 4 % Lidocaine

NDC 69452-393-63

a+health™

maximum strength

pain relief

roll-on

lidocaine 4% HCl/

topical analgesic

odor free

no mess applicator

without irritation

2.5 fl oz (74mL)

with aloe

carton

PAIN RELIEF ROLL-ON 
lidocaine 4% liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69452-393
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:69452-393-631 in 1 CARTON02/20/2023
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 not finalpart34802/20/2023
Labeler - Bionpharma Inc. (079637826)
Registrant - Bionpharma Inc. (079637826)
Establishment
NameAddressID/FEIBusiness Operations
Pharma Nobis, LLC118564114manufacture(69452-393) , analysis(69452-393) , label(69452-393) , pack(69452-393)

Revised: 2/2023
Document Id: f607b6e9-27eb-1978-e053-2995a90a7bcd
Set id: f607b6dc-8d13-604a-e053-2995a90a59ab
Version: 1
Effective Time: 20230220
 
Bionpharma Inc.