Label: BLISTEX MEDICATED LIP BALM- dimethicone, oxybenzone, and padimate o stick
-
Contains inactivated NDC Code(s)
NDC Code(s): 10157-9822-1, 10157-9822-3, 10157-9822-4 - Packager: Blistex 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 20, 2018
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
- Uses
- Warnings
- Directions
-
Inactive ingredients
beeswax, camphor, cetyl alcohol, cetyl palmitate, euphorbia cerifera (candelilla) wax, flavors, isopropyl myristate, isopropyl palmitate, isopropyl stearate, lanolin, lanolin oil, menthol, methylparaben, mineral oil, ozokerite, paraffin, petrolatum, polybutene, propylparaben, red 6 lake, theobroma cacao (cocoa) seed butter, titanium dioxide
- Other information
- PRINCIPAL DISPLAY PANEL - 4.25 g Cylinder Blister Pack
-
INGREDIENTS AND APPEARANCE
BLISTEX MEDICATED LIP BALM
dimethicone, oxybenzone, and padimate o stickProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:10157-9822 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Dimethicone (UNII: 92RU3N3Y1O) (Dimethicone - UNII:92RU3N3Y1O) Dimethicone 2 g in 100 g Oxybenzone (UNII: 95OOS7VE0Y) (Oxybenzone - UNII:95OOS7VE0Y) Oxybenzone 2.5 g in 100 g Padimate O (UNII: Z11006CMUZ) (Padimate O - UNII:Z11006CMUZ) Padimate O 6.6 g in 100 g Inactive Ingredients Ingredient Name Strength yellow wax (UNII: 2ZA36H0S2V) cetyl alcohol (UNII: 936JST6JCN) cetyl palmitate (UNII: 5ZA2S6B08X) candelilla wax (UNII: WL0328HX19) isopropyl myristate (UNII: 0RE8K4LNJS) isopropyl palmitate (UNII: 8CRQ2TH63M) isopropyl stearate (UNII: 43253ZW1MZ) lanolin (UNII: 7EV65EAW6H) lanolin oil (UNII: OVV5IIJ58F) menthol, unspecified form (UNII: L7T10EIP3A) methylparaben (UNII: A2I8C7HI9T) mineral oil (UNII: T5L8T28FGP) paraffin (UNII: I9O0E3H2ZE) petrolatum (UNII: 4T6H12BN9U) polybutene (1400 MW) (UNII: 1NA5AO9GH7) propylparaben (UNII: Z8IX2SC1OH) D&C Red No. 6 (UNII: 481744AI4O) aluminum oxide (UNII: LMI26O6933) cocoa butter (UNII: 512OYT1CRR) titanium dioxide (UNII: 15FIX9V2JP) Product Characteristics Color PINK Score Shape BULLET Size Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:10157-9822-3 3 in 1 BLISTER PACK 11/01/2010 1 NDC:10157-9822-1 4.25 g in 1 CYLINDER; Type 0: Not a Combination Product 2 NDC:10157-9822-4 4 in 1 BLISTER PACK 11/01/2010 2 NDC:10157-9822-1 4.25 g in 1 CYLINDER; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH FINAL part347 11/01/2010 Labeler - Blistex Inc. (005126354) Establishment Name Address ID/FEI Business Operations Blistex Inc. 005126354 MANUFACTURE(10157-9822)