ROYAL JELLY SCAR BALM- dimethicone cream 
Jafra Cosmetics International Inc

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.

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Active ingredient

Dimethicone 2%

Purpose

Skin protectant

Uses

Temporarily protects and helps relieve chapped or cracked skin

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.

Direction

• apply as needed

Inactive ingredients

Water/Aqua, Caprylic/Capric Triglyceride, Aluminum Sucrose Octasulfate, Croton Lechleri Resin Extract, Glycerin, Royal Jelly, Honey/Mel, Withania Somniferia (Winter Cherry) Extract, Nelumbo Nucifera (Lotus) Extract, Polyglyceryl-3 Methylglucose Distearate, C12-15 Alkyl Benzoate, Glyceryl Stearate, Butyrospermum Parkii (Shea Butter) Fruit, Polyacrylamide, C13-14 Isoparaffin, Laureth-7, Theobroma Cocoa Seed Butter, Cetyl Alcohol, Rosa Moschata Seed Oil, Beta-Glucan, Saccharomyces Lysate Extract, Tocopheryl Acetate, DMDM Hydantoin, Panthenol, Diazolidinyl Urea, Trisodium EDTA

Product label

image description

ROYAL JELLY SCAR BALM 
dimethicone cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68828-004
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O) DIMETHICONE2 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
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)  
WITHANOLIDE D (UNII: XY366XV8JT)  
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:68828-004-011 in 1 CARTON06/15/2022
130 mL in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34706/15/2022
Labeler - Jafra Cosmetics International Inc (041676479)
Registrant - Jafra Cosmetics International Inc (041676479)
Establishment
NameAddressID/FEIBusiness Operations
Distribuidora Comercial Jafra, S.A. de C.V.951612777manufacture(68828-004)

Revised: 6/2022
 
Jafra Cosmetics International Inc