Label: DERMA NUMB PAIN RELIEF- lidocaine hcl gel
- NDC Code(s): 70188-005-01, 70188-005-04
- Packager: A.T.S. Laboratories, LLC
- 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 January 14, 2022
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- Active Ingredients
- Purpose
- Uses
- Warnings
- DO NOT USE
- STOP USE
- KEEP OUT OF REACH OF CHILDREN
- Directions
- Inactive Ingredients
- Other Information
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- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
DERMA NUMB PAIN RELIEF
lidocaine hcl gelProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:70188-005 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength LIDOCAINE HYDROCHLORIDE (UNII: V13007Z41A) (LIDOCAINE - UNII:98PI200987) LIDOCAINE HYDROCHLORIDE 40 mg in 1 g Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) ACHILLEA MILLEFOLIUM (UNII: 2FXJ6SW4PK) YUCCA SCHIDIGERA (UNII: 08A0YG3VIC) CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) SODIUM METABISULFITE (UNII: 4VON5FNS3C) CAPRYLYL GLYCOL (UNII: 00YIU5438U) EDETATE DISODIUM (UNII: 7FLD91C86K) METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:70188-005-01 28 g in 1 PACKAGE; Type 0: Not a Combination Product 07/01/2015 2 NDC:70188-005-04 113 g in 1 PACKAGE; Type 0: Not a Combination Product 07/01/2015 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part348 07/01/2015 Labeler - A.T.S. Laboratories, LLC (080013331)