NATURASIL MITE B GONE TREATMENT KIT- sulfur, thuja occidentalis kit

Naturasil Mite B Gone TREATMENT Kit by

Drug Labeling and Warnings

Naturasil Mite B Gone TREATMENT Kit by is a Homeopathic medication manufactured, distributed, or labeled by Nature's Innovation, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Topical Mite and Multi-Purpose Itch Lotion

Drug Facts

Active Ingredients:

Sulfur 1X HPUS

The letters HPUS indicate the component(s) in this product is (are) officially monographed in the Homeopathic Pharmacopeia of the United States.

Purpose

Mite Symptom Relief

INDICATIONS & USAGE

Uses: Symptomatic treatment of mite infections.

WARNINGS

Warnings: For external use only. Ask a doctor before use if pregnant or nursing. Avoid using near eyes, mouth or mucous membranes. If eye contact occurs, rinse thoroughly with water and consult a doctor.

Keep out of reach of children. Do not use if tamper evident seal is broken. In case of ingestion, call Poison Control Center hotline immediately at 1-800-222-1222.

DOSAGE & ADMINISTRATION

Directions: SHAKE WELL. Cleanse skin thoroughly with Mite-B-Gone Soap before applying. Cover the affected area with lotion 2-3 times per day. If excessive drying of the skin or rash occurs, reduce the application of lotion or discontinue use. Some may be sensitive to sulfur or essential oils. Skin test for tolerability. If irritation or reaction occurs, discontinue use.

INACTIVE INGREDIENT

Inactive Ingredients: Aqua, Carbomer, Cetearyl Alcohol, Glyceryl Stearate, Helianthus Annus (Sunflower) Seed Oil, Phenoxyethanol, Polysorbate 20, Potassium Sorbate, Sodium Hydroxide, Tea Tree Oil.

Topical Mite and Multi-Purpose Itch Soap

Drug Facts

Active Ingredients:

Sulfur 1X HPUS, Thuja Occidentalis 6X HPUS

The letters HPUS indicate the component(s) in this product is (are) officially monographed in the Homeopathic Pharmacopeia of the United States.

Purpose

Mite Symptom Relief

INDICATIONS & USAGE

Uses: Symptomatic homeopathic topical treatment of common parasitic skin infections.

WARNINGS

Warnings: For external use only. Ask a doctor before use if pregnant or nursing. Avoid using near eyes, mouth or mucous membranes. If contact with eyes or mucous membranes occurs, rinse thoroughly with water.

Keep out of reach of children. In case of ingestion, call Poison Control Center hotline immediately at 1-800-222-1222

DOSAGE & ADMINISTRATION

Directions: Use soap at least 2 times per day, for 4-10 days. Drying of skin may occur. Some individuals may be sensitive to essential oils. Skin test for tolerability. If irritation or reaction occurs, discontinue use.

INACTIVE INGREDIENT

Inactive Ingredients: Aqua, Citric Acid, Cocamidopropyl Betaine, Cocos Nucifera (coconut oil), Glycerin, Glyceryl Laurate, Lavender Oil, Pentasodium Pentetate, Propylene Glycol, Sodium Chloride, Sodium Citrate, Sodium Laurate, Sodium Myristate, Sodium Oleate, Sodium Stearate, Sodium Thiosulfate, Sorbitol, Tetrasodium Etidronate, Titanium Dioxide, Trisodium Sulfosuccinate.

SPL UNCLASSIFIED SECTION

Fast Relief for Serious Itch

10% SULFUR

Instant Itch Relief from Mites, Insect Bites, Acne, and Fungus
All-Natural Blend of Anti-Inflammatory Ingredients
10% Premium Volcanic Sulfur
Lasting Relief WITHOUT Harsh Chemicals or Irritation

GOOD MANUFACTURING PRACTICE
QUALITY PRODUCT

CRUELTY FREE
NOT TESTED ON ANIMALS

ALL NATURAL 100% GUARANTEE

Mite-B-Gone Topical Mite and Multipurpose Itch Soap and Lotion are formulated with a natural blend of nourishing essential oils that bring quick relief of mites, acne, seborrheic dermatitis, eczema, tinea, nail fungus, and other fungal infections. Our Anti-inflammatory blends work quickly to counteract itching and clear up outbreaks. Mite-B-Gone has 10% premium volcanic sulfur and tea tree essential oil to stop the intense itch and help provide fast relief. The added sunflower oil helps to hydrate and soothe your skin. Mite-B-Gone gives you lasting relief WITHOUT harsh chemicals or irritation. Proudly small batched by our skilled production technicians in our FDA registered facility right outside of Atlanta, Georgia, USA.

Lotion and soap MUST be used together for optimum relief and healing. Thoroughly wash affected area with Mite-B-Gone Soap and dry. Next, apply Mite-B-Gone Lotion 2-3 times daily. Drying of skin may occur. Some individuals may be sensitive to essential oils. Skin test for tolerability. If irritation or reaction occurs, discontinue use.

Questions? Comments? www.naturasil.com
1-866-371-2499 Mfd. by: Nature’s Innovation, Inc.
5317 Palmero Court, Buford, GA 30518

*These statements or claims are based upon traditional homeopathic practice. They have not been reviewed by the Food & Drug Administration. “X “is a homeopathic dilution.

Tips & Tricks
To Get The Most Out Of Your Lotion

Shake Well

Clean Area
Cleanse skin before application

Cover Generously
Cover affected area 2-3 times per day

Speedy Relief
Use in conjunction with Mite-B-Gone Sulfur Lavender Soap

Cold Open
Refrigerate 2-3 hrs before opening for extra cooling relief

MADE IN USA

Packaging

INGREDIENTS AND APPEARANCE

NATURASIL MITE B GONE TREATMENT KIT 
sulfur, thuja occidentalis kit

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 10893-531

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 10893-531-02	1 in 1 KIT; Type 0: Not a Combination Product	02/12/2024

Quantity of Parts
Part #	Package Quantity	Total Product Quantity
Part 1	1 BOTTLE	118.3 mL
Part 2	1 CARTON	113.3 g

Part 1 of 2

NATURASIL MITE B GONE 
sulfur lotion

Product Information
Item Code (Source)	NDC: 10893-530
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
SULFUR (UNII: 70FD1KFU70) (SULFUR - UNII:70FD1KFU70)	SULFUR	1 [hp_X]  in 118.3 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
SUNFLOWER OIL (UNII: 3W1JG795YI)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
POLYSORBATE 20 (UNII: 7T1F30V5YH)
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
TEA TREE OIL (UNII: VIF565UC2G)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 10893-530-04	118.3 mL in 1 BOTTLE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved homeopathic		02/01/2024

Part 2 of 2

NATURASIL  MITE BE GONE
sulfur, thuja occindentalis soap

Product Information
Item Code (Source)	NDC: 10893-660
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
SULFUR (UNII: 70FD1KFU70) (SULFUR - UNII:70FD1KFU70)	SULFUR	1 [hp_X]  in 113.3 g
THUJA OCCIDENTALIS LEAF (UNII: 0T0DQN8786) (THUJA OCCIDENTALIS LEAF - UNII:0T0DQN8786)	THUJA OCCIDENTALIS LEAF	6 [hp_X]  in 113.3 g

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)
COCONUT OIL (UNII: Q9L0O73W7L)
GLYCERIN (UNII: PDC6A3C0OX)
GLYCERYL LAURATE (UNII: Y98611C087)
LAVENDER OIL (UNII: ZBP1YXW0H8)
PENTASODIUM PENTETATE (UNII: 961TOZ5L7T)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
SODIUM CITRATE, UNSPECIFIED FORM (UNII: 1Q73Q2JULR)
SODIUM LAURATE (UNII: K146MR5EXO)
SODIUM MYRISTATE (UNII: 06BLC4V0IV)
SODIUM OLEATE (UNII: 399SL044HN)
SODIUM STEARATE (UNII: QU7E2XA9TG)
SODIUM THIOSULFATE (UNII: HX1032V43M)
SORBITOL (UNII: 506T60A25R)
ETIDRONATE TETRASODIUM (UNII: CZZ9T1T1X4)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
TRISODIUM SULFOSUCCINATE (UNII: 085WB9L09N)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 10893-660-04	113.3 g in 1 CARTON; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved homeopathic		09/11/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved homeopathic		02/12/2024

Labeler - Nature's Innovation, Inc. (602969854)

Establishment
Name	Address	ID/FEI	Business Operations
Nature's Innovation, Inc.		602969854	manufacture(10893-531, 10893-530, 10893-660)