Label: PAIN RELIEF ROLL-ON- lidocaine 4% liquid
- NDC Code(s): 69452-393-63
- Packager: Bionpharma Inc.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph not final
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.
Drug Label Information
Updated February 20, 2023
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- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Active ingredient
- Purpose
- Uses
-
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
- Directions
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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
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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
- temporarary relief of pain
- helps pain-affected areas
without irritation
2.5 fl oz (74mL)
with aloe
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INGREDIENTS AND APPEARANCE
PAIN RELIEF ROLL-ON
lidocaine 4% liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:69452-393 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength LIDOCAINE HYDROCHLORIDE (UNII: V13007Z41A) (LIDOCAINE - UNII:98PI200987) LIDOCAINE HYDROCHLORIDE ANHYDROUS 4 g in 100 mL Inactive Ingredients Ingredient Name Strength 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 Code Package Description Marketing Start Date Marketing End Date 1 NDC:69452-393-63 1 in 1 CARTON 02/20/2023 1 74 mL in 1 BOTTLE, WITH APPLICATOR; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part348 02/20/2023 Labeler - Bionpharma Inc. (079637826) Registrant - Bionpharma Inc. (079637826) Establishment Name Address ID/FEI Business Operations Pharma Nobis, LLC 118564114 manufacture(69452-393) , analysis(69452-393) , label(69452-393) , pack(69452-393)