Label: DYVE COMFORT B- benzocaine, lidocaine gel
-
Contains inactivated NDC Code(s)
NDC Code(s): 70458-104-20 - Packager: AmperSand Biopharmaceuticals
- Category: HUMAN OTC DRUG LABEL
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 March 21, 2018
If you are a healthcare professional or from the pharmaceutical industry please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Active Ingredients
- Purpose
- Uses
-
Warnings
For external use only
Do not use
On large areas of the body or on cut, irritated or swollen skin
On puncture wounds
For more than one week without consulting a doctorWhen using this product:
Use only as directed
Read and follow all direction and warnings on this carton
Do not allow contact with eyes
Do not bandage or apply local heat to the area of use
- Directions
- Other information
- Inactive ingredients
- Questions?
- PRINCIPAL DISPLAY PANEL
-
INGREDIENTS AND APPEARANCE
DYVE COMFORT B
benzocaine, lidocaine gelProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:70458-104 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL 1 g in 100 g BENZOCAINE (UNII: U3RSY48JW5) (BENZOCAINE - UNII:U3RSY48JW5) BENZOCAINE 20 g in 100 g Inactive Ingredients Ingredient Name Strength ISOPROPYL PALMITATE (UNII: 8CRQ2TH63M) LECITHIN, SOYBEAN (UNII: 1DI56QDM62) POLOXAMER 407 (UNII: TUF2IVW3M2) BENZYL ALCOHOL (UNII: LKG8494WBH) WATER (UNII: 059QF0KO0R) POLYGLYCERYL-4 STEARATE (UNII: VLC3W3U1PE) PALM KERNEL OIL (UNII: B0S90M0233) POLYGLYCERYL-4 OLEATE (UNII: 15B05TY4GX) SODIUM HYDROXIDE (UNII: 55X04QC32I) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:70458-104-20 1 in 1 BOX 04/01/2018 1 200 g in 1 JAR; 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 04/01/2018 Labeler - AmperSand Biopharmaceuticals (080111681)