ROYAL JELLY SCAR JAFRA- dimethicone cream

Royal Jelly Scar by

Drug Labeling and Warnings

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

Drug Details [pdf]

ACTIVE INGREDIENT

​Active Ingredient             Purpose

Dimethicone 2%                 Skin Protectant

PURPOSE

​Uses

• Temporarily protects and helps relieve chapped or cracked skin

KEEP OUT OF REACH OF CHILDREN

​Keep out of reach of children. ​If swallowed, get medical help or contact a Poison Control Center rigth away

INDICATIONS & USAGE

​Stop use and as a doctor if

• condition worsens
• symptoms last more than 7 days or clear up and occur again within a few days

WARNINGS

​Warnings

• For external use only
• When using this product do not get into eyes
• Do not use on

- deep or puncture wounds

- animal bites

- serious burns

DOSAGE & ADMINISTRATION

​Directions

• Apply as needed

INACTIVE INGREDIENT

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

PRINCIPAL DISPLAY PANEL

JAFRA

Royal Jelly

Scar Balm

Skin Protectant

30 ml e 1 FL OZ (US)

INGREDIENTS AND APPEARANCE

ROYAL JELLY SCAR  JAFRA
dimethicone cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 68828-401
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)
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)
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: 68828-401-02	1 in 1 BOX	01/27/2017
1	NDC: 68828-401-01	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 final	part347	01/27/2017

Labeler - Jafra Cosmetics International Inc (041676479)

Registrant - Jafra Cosmetics International Inc (041676479)

Establishment
Name	Address	ID/FEI	Business Operations
Jafra Manufacturing, S.A. de C.V.		814732061	manufacture(68828-401)