Label: ROYAL JELLY SCAR BALM- dimethicone cream
- NDC Code(s): 68828-004-01
- Packager: Distribuidora Comercial Jafra, S.A. de C.V.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated January 2, 2025
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- Active ingredient
- Purpose
- Uses
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Warning
For external use only
When using this product● do not get into eyes
Stop use and ask a doctor if ● condition worsens ● symptoms last more than 7 days or clear up and occur again in a few days
Do not use on● deep or puncture wounds ● animal bites ● serious burns
Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away. - Directions
- KEEP OUT OF REACH OF CHILDREN
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Inactive ingredients
Water, Caprylic/Capric Triglyceride, Polyglyceryl-3 Methylglucose Distearate, C12-15 Alkyl Benzoate, Glyceryl Stearate, Butyrospermum Parkii (Shea) Butter, Glycerin, Theobroma Cacao (Cocoa) Seed Butter, Cetyl Alcohol, Rosa Moschata Seed Oil, Polyacrylamide, Aluminum Sucrose Octasulfate, Croton Lechleri Resin Extract, Tocopheryl Acetate, C13-14 Isoalkane, DMDM Hydantoin, Panthenol, Diazolidinyl Urea, Laureth-7, Trisodium EDTA, Honey, Royal Jelly Powder, Withania Somnifera Extract, Beta-Glucan, Nelumbo Nucifera Extract, Saccharomyces Lysate Extract
- SPL UNCLASSIFIED SECTION
- Product label
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INGREDIENTS AND APPEARANCE
ROYAL JELLY SCAR BALM
dimethicone creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:68828-004 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 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U) SUCRALFATE (UNII: XX73205DH5) CROTON LECHLERI RESIN (UNII: GGG6W25C63) GLYCERIN (UNII: PDC6A3C0OX) ROYAL JELLY (UNII: L497I37F0C) HONEY (UNII: Y9H1V576FH) WITHANIA SOMNIFERA FLOWER (UNII: 2HZ95R7082) NELUMBO NUCIFERA WHOLE (UNII: 622D93A1R1) POLYGLYCERYL-3 METHYLGLUCOSE DISTEARATE (UNII: W19EIO0DBE) ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ) GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4) SHEA BUTTER (UNII: K49155WL9Y) POLYACRYLAMIDE (1500 MW) (UNII: 5D6TC4BRWV) C13-14 ISOPARAFFIN (UNII: E4F12ROE70) LAURETH-7 (UNII: Z95S6G8201) COCOA BUTTER (UNII: 512OYT1CRR) CETYL ALCOHOL (UNII: 936JST6JCN) ROSA MOSCHATA SEED OIL (UNII: T031ZE559T) YEAST .BETA.-D-GLUCAN (UNII: 44FQ49X6UN) SACCHAROMYCES LYSATE (UNII: R85W246Z1C) .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) DMDM HYDANTOIN (UNII: BYR0546TOW) PANTHENOL (UNII: WV9CM0O67Z) DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4) EDETATE TRISODIUM (UNII: 420IP921MB) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:68828-004-01 1 in 1 CARTON 06/15/2022 1 30 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 Drug M016 06/15/2022 Labeler - Distribuidora Comercial Jafra, S.A. de C.V. (951612777) Registrant - Jafra Cosmetics International Inc (031183599) Establishment Name Address ID/FEI Business Operations Distribuidora Comercial Jafra, S.A. de C.V. 951612777 manufacture(68828-004)
