HERBITUAL SKIN PROTECTANT CREAM- dimethicone cream 
Prime Matter Labs West

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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Herbitual ATOPIC SKINN DEFENSE Skin Protectant Cream

Active Ingredient

Dimethicone 1%

Purpose

Skin Protectant

Uses

Helps prevent and temporarily protects and helps relieve, chapped or cracked skin.

Warnings

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 within 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 immediately.

Directions

Apply as needed. For best results, apply to damp skin after bathing or showering.

Inactive Ingredients:

Water, Emu Oil, Caprylic/Capric Triglyceride, Butyrospermum Parkii Butter, Glycerin, Glyceryl Stearate SE, Stearyl Alcohol, Euphorbia Cerifera Wax, Curcuma Longa Root Extract, Aconitum Carmichaelli Root Extract, Astragalus Membranaceous Root Extract, Coptis Chinensis Root Extract, Glycyrrhiza Uralensis Root Extract, Phellodendron Chinese Bark Extract, Rheum Plamatum Root Extract, Salvia Miltiorrhiza Root Extract, Sophora Flavescens Root Extract, Phenoxyethanol, Xanthan Gum, Caprylyl Glycol, Potassium Sorbate, Sodium Benzoate, Ethylhexylglycerin, Hexylene Glycol.

Distributed by Herbitual LLC.

2699 1/2 N Beachwood Drive

Suite 212 Los angeles CA 90068

www.herbitualskin.com | @herbitualskin

Herbitual
ATOPIC SKINN DEFENSE
Skin Protectant Cream

Principal Display Label

HERBITUAL  SKIN PROTECTANT CREAM
dimethicone cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:82956-0001
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DIMETHICONE 100 (UNII: RO266O364U) (DIMETHICONE 100 - UNII:RO266O364U) DIMETHICONE 1009.98 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
STEARYL ALCOHOL (UNII: 2KR89I4H1Y)  
TURMERIC (UNII: 856YO1Z64F)  
ACONITUM CARMICHAELII ROOT (UNII: XJ28061U1S)  
RHEUM PALMATUM ROOT (UNII: G025DAL7CE)  
SALVIA MILTIORRHIZA ROOT (UNII: 1693AM5SBN)  
SOPHORA FLAVESCENS ROOT (UNII: IYR6K8KQ5K)  
CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
SODIUM BENZOATE (UNII: OJ245FE5EU)  
HEXYLENE GLYCOL (UNII: KEH0A3F75J)  
ASTRAGALUS MONGHOLICUS ROOT (UNII: 922OP8YUPF)  
PHELLODENDRON AMURENSE BARK (UNII: PBG27B754G)  
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
GLYCERIN (UNII: PDC6A3C0OX)  
SHEA BUTTER (UNII: K49155WL9Y)  
CANDELILLA WAX (UNII: WL0328HX19)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
GLYCERYL STEARATE SE (UNII: FCZ5MH785I)  
WATER (UNII: 059QF0KO0R)  
EMU OIL (UNII: 344821WD61)  
GLYCYRRHIZA URALENSIS ROOT (UNII: 42B5YD8F0K)  
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
XANTHAN GUM (UNII: TTV12P4NEE)  
COPTIS CHINENSIS ROOT (UNII: CXS4LJR7EL)  
Product Characteristics
ColoryellowScore    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:82956-0001-328 mL in 1 JAR; Type 0: Not a Combination Product01/24/2023
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalM01601/24/2023
Labeler - Prime Matter Labs West (118568102)
Establishment
NameAddressID/FEIBusiness Operations
Prime Matter Labs West118568102manufacture(82956-0001) , pack(82956-0001) , label(82956-0001)

Revised: 1/2023
Document Id: f309e158-96c8-241e-e053-2995a90a7bf5
Set id: f309e158-96c7-241e-e053-2995a90a7bf5
Version: 1
Effective Time: 20230119
 
Prime Matter Labs West