Royal Jelly Body Hand and Cuticle Complex

Royal Jelly Body Hand and Cuticle Complex by

Drug Labeling and Warnings

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

Drug Details [pdf]

ROYAL JELLY BODY HAND AND CUTICLE COMPLEX- dimethicone cream 
Jafra Cosmetics International

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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Royal Jelly Body Hand and Cuticle Complex

Active Ingredients Purpose

Dimethicone 1.5% Skin Protectant

Use

• Helps prevent and temporarily protects chapped or cracked skin

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

Stop use and ask a doctor if

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

Warnings

For external use only

when using this product

• do not get into eyes

Do not use on

• deep puncture wounds
• animal bites
• serious burns

Directions

• Apply as needed

Inactive ingredients

Water/Aqua, Prunus Armeniaca (Apricot) Kernel Oil, Prunus Amygdalus Dulcis (Sweet Almond) Oil, Hydrogenated Vegetable Oil/ Olus Oil, Cetearyl Alcohol, Ceteareth-20, C12-15 Alkyl Benzoate, Glycerin, Sodium PCA, Butyrospermum Parkii (Shea Butter), Bis-Diglyceryl Polyacyladipate-2, Cetyl Alcohol, Stearyl Stearate, Myristyl Myristate, Royal Jelly Powder, Lecithin, Dipropylene Glycol, Royal Jelly, Tetrapeptide-45, Hydrogenated Lecithin, Garcinia Indica Seed Butter, Theobroma Cocoa Butter, Chamomilla Recutita (Matricaria) Extract, Morus Alba Extract, Lonicera Caprifolium (Honeysuckle) Flower extract, Ipomoea Digitata (Fingerleaf Morning Glory) Extract, Withania Somnifera (Winter Cherry) Extract, Vigna Radiata (Mung Bean) Extract, DMDM Hydantoin, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Triethanolamine, Fragrance/Parfum, Allantoin, Panthenol, Tocopherol, Trisodium EDTA, Phenoxyethanol, Hexylene Glycol, Caprylyl Glycol, Potassium Sorbate, PEG-4 Laurate, Iodopropynyl Butylcarbamate, PEG-4, PEG-4 Dilaurate, Phenethyl Alcohol, Ethylhexylglycerin, Maltodextrin

Product label

ROYAL JELLY BODY HAND AND CUTICLE COMPLEX 
dimethicone cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 68828-445
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O)	DIMETHICONE	1.5 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
BIS-DIGLYCERYL POLYACYLADIPATE-2 (UNII: 6L246LAM9T)
DIPROPYLENE GLYCOL (UNII: E107L85C40)
MYRISTYL MYRISTATE (UNII: 4042ZC00DY)
COCOA BUTTER (UNII: 512OYT1CRR)
APRICOT KERNEL OIL (UNII: 54JB35T06A)
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
GLYCERIN (UNII: PDC6A3C0OX)
MUNG BEAN (UNII: 1LIB31N73G)
DMDM HYDANTOIN (UNII: BYR0546TOW)
CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO)
HEXYLENE GLYCOL (UNII: KEH0A3F75J)
SODIUM PYRROLIDONE CARBOXYLATE (UNII: 469OTG57A2)
SHEA BUTTER (UNII: K49155WL9Y)
LECITHIN, SOYBEAN (UNII: 1DI56QDM62)
ROYAL JELLY (UNII: L497I37F0C)
GARCINIA INDICA SEED BUTTER (UNII: US2H3D7800)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
POLYETHYLENE GLYCOL 200 (UNII: R95B8J264J)
ALLANTOIN (UNII: 344S277G0Z)
PANTHENOL (UNII: WV9CM0O67Z)
TOCOPHEROL (UNII: R0ZB2556P8)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
STEARYL STEARATE (UNII: 5WX2EGD0DK)
ALMOND OIL (UNII: 66YXD4DKO9)
POLYOXYL 20 CETOSTEARYL ETHER (UNII: YRC528SWUY)
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)
MATRICARIA CHAMOMILLA WHOLE (UNII: G0R4UBI2ZZ)
LONICERA CAPRIFOLIUM FLOWER (UNII: 5N1WD9784U)
IODOPROPYNYL BUTYLCARBAMATE (UNII: 603P14DHEB)
CETYL ALCOHOL (UNII: 936JST6JCN)
HYDROGENATED SOYBEAN LECITHIN (UNII: H1109Z9J4N)
PEG-4 LAURATE (UNII: AYF4VM3N1Z)
TROLAMINE (UNII: 9O3K93S3TK)
PEG-4 DILAURATE (UNII: KCR71CW036)
EDETATE TRISODIUM (UNII: 420IP921MB)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 68828-445-01	75 mL in 1 CARTON; Type 0: Not a Combination Product	09/02/2021	04/01/2023

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part347	09/02/2021	04/01/2023

Labeler - Jafra Cosmetics International (041676479)

Establishment
Name	Address	ID/FEI	Business Operations
Distribuidora Comercial Jafra, S.A. de C.V.		951612777	manufacture(68828-445)

Revised: 7/2023

Document Id: 014f0c32-3dc0-14a7-e063-6394a90aaf86

34390-5

Set id: c85e96a9-a593-3813-e053-2995a90a0771

Version: 4

Effective Time: 20230725