ROYAL JELLY SCAR BALM- dimethicone cream

Royal Jelly Scar Balm by

Drug Labeling and Warnings

Royal Jelly Scar Balm by is a Otc medication manufactured, distributed, or labeled by Jafra Cosmetics International Inc, Distribuidora Comercial Jafra, S.A. de C.V.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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.

Directions

 apply as needed

KEEP OUT OF REACH OF CHILDREN

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

Questions?Call 1-800-551-2345 or visit www.jafra.com

Product label

INGREDIENTS AND APPEARANCE

ROYAL JELLY SCAR BALM 
dimethicone cream

Product 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)