Label: LIPOCAINE 5- lidocaine 5% cream
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Contains inactivated NDC Code(s)
NDC Code(s): 63135-811-04, 63135-811-30 - Packager: ESBA LABORATORIES INC.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph 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 December 7, 2021
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Active ingredient:
- Purpose
- Use
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Warnings
For external use only.
When using this product:
- avoid contact with eyes
- do not use in large quantities, particularly over raw surfaces or blistered areas
- do not put in rectum
- do not exceed recommended dosage unless directed by a doctor.
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Directions:
- When practical, clean area with mild soap and warm water and rinse thoroughly
- Gently dry by patting or blotting with toilet tissue or soft cloth before applying
- Adults and children 12 years old and older: Apply externally to the affected area up to 6 times a day
- Children under 12 years of age: consult a doctor.
- Other information:
- Inactive ingredients:
- Questions
- Label on tube and outer carton
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INGREDIENTS AND APPEARANCE
LIPOCAINE 5
lidocaine 5% creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:63135-811 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength LIDOCAINE (UNII: 98PI200987) (LIDOCAINE - UNII:98PI200987) LIDOCAINE 5 g in 100 g Inactive Ingredients Ingredient Name Strength ALLANTOIN (UNII: 344S277G0Z) 0.01 g in 100 g XANTHAN GUM (UNII: TTV12P4NEE) 1.5 g in 100 g SUCROSE DISTEARATE (UNII: 33X4X4B90S) 2 g in 100 g .BETA.-SITOSTEROL (UNII: S347WMO6M4) 0.5 g in 100 g CAPRYLHYDROXAMIC ACID (UNII: UPY805K99W) 0.12 g in 100 g GLYCERYL CAPRYLATE (UNII: TM2TZD4G4A) 0.6 g in 100 g GLYCERIN (UNII: PDC6A3C0OX) 0.48 g in 100 g CETYL PALMITATE (UNII: 5ZA2S6B08X) 5 g in 100 g CETYL ALCOHOL (UNII: 936JST6JCN) 0.25 g in 100 g WATER (UNII: 059QF0KO0R) 71.77 g in 100 g ISOSTEARYL ALCOHOL (UNII: Q613OCQ44Y) 0.25 g in 100 g LECITHIN, SUNFLOWER (UNII: 834K0WOS5G) 0.01 g in 100 g TRIETHYL CITRATE (UNII: 8Z96QXD6UM) 10 g in 100 g SUCROSE STEARATE (UNII: 274KW0O50M) 2 g in 100 g .ALPHA.-TOCOPHEROL ACETATE, DL- (UNII: WR1WPI7EW8) 0.5 g in 100 g ALOE VERA LEAF (UNII: ZY81Z83H0X) 0.01 g in 100 g Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:63135-811-30 1 in 1 CARTON 03/18/2019 1 30 g in 1 TUBE; Type 0: Not a Combination Product 2 NDC:63135-811-04 113 g in 1 TUBE; Type 0: Not a Combination Product 03/18/2019 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part346 03/18/2019 Labeler - ESBA LABORATORIES INC. (963303490) Registrant - Esba Laboratories Inc (963303490) Establishment Name Address ID/FEI Business Operations ESBA LABORATORIES INC. 963303490 manufacture(63135-811)
