Label: TOPICAL ANESTHETIC ANORECTAL CREAM NUMB AND NUMBER- lidocaine cream
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Contains inactivated NDC Code(s)
NDC Code(s): 68848-001-01, 68848-001-02, 68848-001-03, 68848-001-04 - Packager: Dermtech Labs Inc. dba GD Labs
- 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 January 3, 2017
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- ACTIVE INGREDIENT
- PURPOSE
- KEEP OUT OF REACH OF CHILDREN
- INDICATIONS & USAGE
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WARNINGS
- For Rectal use only
- For external use on intact skin only
- Do not use if pregnant or breast-feeding
- Do not exceed the recommended daily dosage unless directded by a doctor
- Avoid contact with eyes and mucous membranes
- You may experience temporary redness or stinging where the product is applied
- If irritation persists, consult your doctor
- Do not put product into the rectum by using fingers or any mechanical device or applicator
- DOSAGE & ADMINISTRATION
- INACTIVE INGREDIENT
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
TOPICAL ANESTHETIC ANORECTAL CREAM NUMB AND NUMBER
lidocaine creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:68848-001 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 CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO) BENZYL ALCOHOL (UNII: LKG8494WBH) POLYOXYL 20 CETOSTEARYL ETHER (UNII: YRC528SWUY) CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S) CHOLESTEROL (UNII: 97C5T2UQ7J) DIETHYLENE GLYCOL MONOETHYL ETHER (UNII: A1A1I8X02B) HYDROGENATED SOYBEAN LECITHIN (UNII: H1109Z9J4N) POLYSORBATE 80 (UNII: 6OZP39ZG8H) PPG-12/SMDI COPOLYMER (UNII: 1BK9DDD24E) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) TROLAMINE (UNII: 9O3K93S3TK) WATER (UNII: 059QF0KO0R) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:68848-001-02 1 in 1 PACKAGE 08/11/2016 1 NDC:68848-001-01 54 g in 1 PACKAGE; Type 0: Not a Combination Product 2 NDC:68848-001-04 1 in 1 PACKAGE 08/11/2016 2 NDC:68848-001-03 600 g in 1 PACKAGE; 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 08/11/2016 Labeler - Dermtech Labs Inc. dba GD Labs (148077899) Registrant - Dermtech Labs Inc. dba GD Labs (148077899) Establishment Name Address ID/FEI Business Operations VEGE-KURL, INC 021072509 manufacture(68848-001)
