Label: RECTICARE- lidocaine and glycerin cloth
- NDC Code(s): 0496-0980-65, 0496-0980-76
- Packager: Ferndale 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 November 18, 2019
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- Official Label (Printer Friendly)
- Active Ingredients
- Purpose
- Uses
-
Warnings
For external use only
Do not
- exceed the recommended daily dosage unless directed by a doctor
- put this product into the rectum by using fingers or any mechanical device or applicator
- Directions
- Inactive Ingredients
- Package Label
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INGREDIENTS AND APPEARANCE
RECTICARE
lidocaine and glycerin clothProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:0496-0980 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength LIDOCAINE (UNII: 98PI200987) (LIDOCAINE - UNII:98PI200987) LIDOCAINE 50 mg in 1 g GLYCERIN (UNII: PDC6A3C0OX) (GLYCERIN - UNII:PDC6A3C0OX) GLYCERIN 200 mg in 1 g Inactive Ingredients Ingredient Name Strength BENZYL ALCOHOL (UNII: LKG8494WBH) ANHYDROUS CITRIC ACID (UNII: XF417D3PSL) WATER (UNII: 059QF0KO0R) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0496-0980-65 12 in 1 CARTON 01/01/2016 1 NDC:0496-0980-76 6 g in 1 POUCH; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part346 01/01/2016 Labeler - Ferndale Laboratories, Inc. (005320536) Registrant - Ferndale Laboratories, Inc. (005320536) Establishment Name Address ID/FEI Business Operations Ferndale Laboratories, Inc. 005320536 manufacture(0496-0980)