Label: KENDRA SKIN PROTECTION AND PAIN RELIEF FOR HAIR REMOVAL- lanolin, petrolatum and lidocaine kit
- NDC Code(s): 67234-048-01
- Packager: Natureplex, LLC
- 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 October 20, 2017
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- ACTIVE INGREDIENT
- Use
- Warnings
- Directions
- Other information
- Inactive ingredients
- Questions or Comments?
- SPL UNCLASSIFIED SECTION
- Active ingredient
- Purpose
- Use
-
Warnings
For external use only
Avoid contact with the eyes
Do Not Use
- if you are allergic to any ingredient in lidocaine cream or to similar medicines (e.g., local anesthetics such as benzocaine)
- in large quantities, particularly over raw surfaces or blistered areas
Ask a doctor before use
- if you have had an allergic reaction (e.g., rash, hives, dizziness) to any anesthetic medicine
- Directions
- Other information
- Inactive ingredients
- Questions or Comments?
- SPL UNCLASSIFIED SECTION
- PRINCIPAL DISPLAY PANEL - Kit Carton
-
INGREDIENTS AND APPEARANCE
KENDRA SKIN PROTECTION AND PAIN RELIEF FOR HAIR REMOVAL
lanolin, petrolatum and lidocaine kitProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:67234-048 Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:67234-048-01 1 in 1 CARTON 06/04/2003 Quantity of Parts Part # Package Quantity Total Product Quantity Part 1 1 TUBE 28 g Part 2 1 TUBE 28 g Part 1 of 2 A AND D
lanolin and petrolatum ointment, augmentedProduct Information Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Lanolin (UNII: 7EV65EAW6H) (Lanolin - UNII:7EV65EAW6H) Lanolin 155 mg in 1 g Petrolatum (UNII: 4T6H12BN9U) (Petrolatum - UNII:4T6H12BN9U) Petrolatum 534 mg in 1 g Inactive Ingredients Ingredient Name Strength YELLOW WAX (UNII: 2ZA36H0S2V) COD LIVER OIL (UNII: BBL281NWFG) LIGHT MINERAL OIL (UNII: N6K5787QVP) MICROCRYSTALLINE WAX (UNII: XOF597Q3KY) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 28 g in 1 TUBE; Type 8: Possible Combination Based on Cross Labeling of Separate Products (Temporary Type) Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part347 06/04/2003 Part 2 of 2 LIDOCAINE PAIN RELIEVING
lidocaine creamProduct Information Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Lidocaine (UNII: 98PI200987) (Lidocaine - UNII:98PI200987) Lidocaine 40 mg in 1 g Inactive Ingredients Ingredient Name Strength ALOE VERA LEAF (UNII: ZY81Z83H0X) SULISOBENZONE (UNII: 1W6L629B4K) CETYL ALCOHOL (UNII: 936JST6JCN) DIMETHYL SULFOXIDE (UNII: YOW8V9698H) CAPRYLYL GLYCOL (UNII: 00YIU5438U) ARGININE (UNII: 94ZLA3W45F) WATER (UNII: 059QF0KO0R) JOJOBA OIL (UNII: 724GKU717M) SODIUM POLYACRYLATE (2500000 MW) (UNII: 05I15JNI2J) STEARIC ACID (UNII: 4ELV7Z65AP) TEA TREE OIL (UNII: VIF565UC2G) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 28 g in 1 TUBE; Type 8: Possible Combination Based on Cross Labeling of Separate Products (Temporary Type) Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part348 12/25/2009 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part347 06/04/2003 Labeler - Natureplex, LLC (062808196) Establishment Name Address ID/FEI Business Operations Natureplex LLC 062808196 MANUFACTURE(67234-048)