Herbitual ATOPIC SKINN DEFENSE Skin Protectant Cream

Herbitual by

Drug Labeling and Warnings

Herbitual by is a Otc medication manufactured, distributed, or labeled by Prime Matter Labs West. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

HERBITUAL  SKIN PROTECTANT CREAM
dimethicone cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 82956-0001
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
DIMETHICONE 100 (UNII: RO266O364U) (DIMETHICONE 100 - UNII:RO266O364U)	DIMETHICONE 100	9.98 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
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
Color	yellow	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 82956-0001-3	28 mL in 1 JAR; Type 0: Not a Combination Product	01/24/2023

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	M016	01/24/2023

Labeler - Prime Matter Labs West (118568102)

Establishment
Name	Address	ID/FEI	Business Operations
Prime Matter Labs West		118568102	manufacture(82956-0001) , pack(82956-0001) , label(82956-0001)

Revised: 1/2023

Document Id: f309e158-96c8-241e-e053-2995a90a7bf5

34390-5

Set id: f309e158-96c7-241e-e053-2995a90a7bf5

Version: 1

Effective Time: 20230119