Label: SURE RESULT SR RENEW- dimethicone cream
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Contains inactivated NDC Code(s)
NDC Code(s): 69837-410-10 - Packager: International Brand Management, LLC
- Category: HUMAN OTC DRUG LABEL
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 June 23, 2017
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- Official Label (Printer Friendly)
- ACTIVE INGREDIENT
- PURPOSE
- INDICATIONS & USAGE
- WARNINGS
- KEEP OUT OF REACH OF CHILDREN
- DOSAGE & ADMINISTRATION
- STORAGE AND HANDLING
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INACTIVE INGREDIENT
Inactive Ingredients Aloe Barbadensis Leaf (Aloe Vera Gel)
Juice, Aqua (Deionized Water), Cetyl Alcohol, DEA-Cetyl
Phosphate, Ethylhexylglycerin, Glyceryl Stearate, Glyceryl
Stearate SE, C13-14 Isoparaffin, Laureth-7, Octyl Palmitate,
PEG-100 Stearate, Phenoxyethanol, Polyacrylamide,
Polysorbate-20, Propylene Glycol, Stearic Acid, Tocopheryl
Acetate (Vitamin E).
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
SURE RESULT SR RENEW
dimethicone creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:69837-410 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O) DIMETHICONE 50 mg in 1 mL Inactive Ingredients Ingredient Name Strength ALOE VERA LEAF (UNII: ZY81Z83H0X) WATER (UNII: 059QF0KO0R) CETYL ALCOHOL (UNII: 936JST6JCN) DIETHANOLAMINE CETYL PHOSPHATE (UNII: 4UG0316V9S) ETHYLHEXYLGLYCERIN (UNII: 147D247K3P) GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4) C13-14 ISOPARAFFIN (UNII: E4F12ROE70) LAURETH-7 (UNII: Z95S6G8201) ETHYLHEXYL PALMITATE (UNII: 2865993309) PEG-100 STEARATE (UNII: YD01N1999R) PHENOXYETHANOL (UNII: HIE492ZZ3T) POLYACRYLAMIDE (10000 MW) (UNII: E2KR9C9V2I) POLYSORBATE 20 (UNII: 7T1F30V5YH) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) STEARIC ACID (UNII: 4ELV7Z65AP) .ALPHA.-TOCOPHEROL ACETATE, DL- (UNII: WR1WPI7EW8) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:69837-410-10 1 in 1 CARTON 06/23/2017 1 118 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 final part347 02/01/2016 Labeler - International Brand Management, LLC (079794940) Establishment Name Address ID/FEI Business Operations International Brand Management, LLC 079794940 manufacture(69837-410)