PREQUEL SKIN UTILITY BALM MULTI-PURPOSE SKIN PROTECTANT- skin protectant balm ointment 
The Center Brands, LLC

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DRUG FACTS

Purpose

Skin Protectant

Active Ingredients

Dimethicone 5.25%

Uses

Temporarily protects and helps releive chafed, chapper or cracked skin

Helps protect fomr the drying effects of wind and cold weather

Warnings

Fox 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 within a few days

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

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

Directions

Apply as needed.

Inactive ingredients

Water (Aqua), Propanediol, Cetearyl Alcohol, Butyrospermum Parkii (Shea) Butter, Undecane, Glycerin, Dipentaerythryityl Hexahydrostearate/Hexastearate/Hexarosinate, Isosorbate Dicaprylate, Cetearyl Olivate, Tridecane, Sorbitan Olivate, Silica, Ceramide NP, Cholesterol, Phytospingosine, Hydrogentaed Lecithin, Centella Asiatica Extract, Sodium Acrylate/Sodium Acryloyldimethyl Taurate Copolymer, Ammonium Acryloyldimethyltuarate/VP Copolymer, Hydrogenated Polydecene, Xanthan Gum, Stearic Acid, Sodium Phytate, Tocopheryl Acetate, Camomilla Recutita Flower Extract, Aloe Barbadensis Leaf Juice, Phenoxyethanol, Ethylhexylglycerin, Citric Acid, Caprylic/Capric Trigylceride, Lactic Acid, Oleic Acid, Laureth-8, Caprylyl Glycol, Caprylhydroxamic Acid, Tocopherol, Potassium Sorbate, Sodium Benzoate, Sodium Sulfate, t-Butyl Acohol

Other Information

• Store in controlled temperatures (4-20°C/39-68°F). Keep in a dark and dry place.

Questions?

Visit prequelskin.com

Principal Display Panel

82800-060-01.jpg

PREQUEL SKIN UTILITY BALM MULTI-PURPOSE SKIN PROTECTANT 
skin protectant balm ointment
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:82800-060
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O) DIMETHICONE5.25 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
PROPANEDIOL (UNII: 5965N8W85T)  
BUTYROSPERMUM PARKII (SHEA) BUTTER UNSAPONIFIABLES (UNII: 0C9AC7D6XU)  
UNDECANE (UNII: JV0QT00NUE)  
DIPENTAERYTHRITYL HEXASTEARATE (UNII: WTF09990PK)  
GLYCERIN (UNII: PDC6A3C0OX)  
ISOSORBIDE DICAPRYLATE (UNII: 0IK29C4889)  
CETEARYL OLIVATE (UNII: 58B69Q84JO)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
CERAMIDE NP (UNII: 4370DF050B)  
CHOLESTEROL (UNII: 97C5T2UQ7J)  
PHYTOSPHINGOSINE (UNII: GIN46U9Q2Q)  
HYDROGENATED SOYBEAN LECITHIN (UNII: H1109Z9J4N)  
CENTELLA ASIATICA (UNII: 7M867G6T1U)  
SODIUM ACRYLATE/SODIUM ACRYLOYLDIMETHYLTAURATE COPOLYMER (4000000 MW) (UNII: 1DXE3F3OZX)  
AMMONIUM ACRYLOYLDIMETHYLTAURATE/VP COPOLYMER (UNII: W59H9296ZG)  
HYDROGENATED POLYDECENE TYPE I (UNII: U333RI6EB7)  
XANTHAN GUM (UNII: TTV12P4NEE)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
HEXASODIUM PHYTATE (UNII: ZBX50UG81V)  
CAMELLIA OLEIFERA LEAF (UNII: 5077EL0C60)  
CHAMOMILE FLOWER OIL (UNII: 60F80Z61A9)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
CITRIC ACID ACETATE (UNII: DSO12WL7AU)  
CAPRYLIC/CAPRIC MONO/DI-GLYCERIDES (UNII: U72Q2I8C85)  
LACTIC ACID (UNII: 33X04XA5AT)  
OLEIC ACID (UNII: 2UMI9U37CP)  
LAURETH-8 (UNII: QU7U88D04I)  
CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
CAPRYLHYDROXAMIC ACID (UNII: UPY805K99W)  
TOCOPHEROL (UNII: R0ZB2556P8)  
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
SODIUM BENZOATE (UNII: OJ245FE5EU)  
SODIUM SULFATE (UNII: 0YPR65R21J)  
TERT-BUTYL ACETATE (UNII: 76N22HKP3X)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:82800-060-011 in 1 PACKAGE10/30/2023
150 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM01610/30/2023
Labeler - The Center Brands, LLC (076228814)

Revised: 10/2023
Document Id: 08f24588-4d88-70b0-e063-6294a90ab195
Set id: 57c0b71d-6099-415c-976d-b96d2f73e9d3
Version: 1
Effective Time: 20231030
 
The Center Brands, LLC