Label: ANAL-ESE- desensitizer cream
- NDC Code(s): 83608-106-05, 83608-106-15
- Packager: Novelties by Nasswalk, 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 August 24, 2023
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Active Ingredient:
- Purpose:
- Uses:
- Warnings:
- Keep out of reach of children.
- Directions:
- Inactive Ingredients:
- ANAL-ESE Cherry Flavored
-
INGREDIENTS AND APPEARANCE
ANAL-ESE
desensitizer creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:83608-106 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength BENZOCAINE (UNII: U3RSY48JW5) (BENZOCAINE - UNII:U3RSY48JW5) BENZOCAINE 7.5 g in 100 mL Inactive Ingredients Ingredient Name Strength GLYCERIN (UNII: PDC6A3C0OX) PEG-8 STEARATE (UNII: 2P9L47VI5E) SACCHARIN SODIUM (UNII: SB8ZUX40TY) FD&C RED NO. 40 (UNII: WZB9127XOA) FD&C YELLOW NO. 6 (UNII: H77VEI93A8) PEG-75 STEARATE (UNII: OT38R0N74H) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:83608-106-05 1 in 1 CARTON 08/07/2023 1 0.5 mL in 1 TUBE; Type 0: Not a Combination Product 2 NDC:83608-106-15 1 in 1 CARTON 08/07/2023 2 1.5 mL in 1 TUBE; 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 08/07/2023 Labeler - Novelties by Nasswalk, Inc. (049455157) Registrant - Novelties by Nasswalk, Inc. (049455157) Establishment Name Address ID/FEI Business Operations Advance Cosmetics Research Laboratories Inc, 874810872 manufacture(83608-106)