Naturasil Mite B Gone TREATMENT Kit

Manufacturer
Nature's Innovation, Inc.
Effective date
2024-02-07
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 02:26:03

Label at a glance#

ProductNaturasil Mite B Gone TREATMENT Kit
Active ingredientSULFUR, THUJA OCCIDENTALIS LEAF
Label structure16 sections

Label contents#

Full prescribing information#

Topical Mite and Multi-Purpose Itch Lotion

SPL UNCLASSIFIED SECTION

Drug Facts

Active Ingredients:

OTC - ACTIVE INGREDIENT SECTION

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

OTC - PURPOSE SECTION

Mite Symptom Relief

INDICATIONS & USAGE SECTION

Uses: Symptomatic treatment of mite infections.

WARNINGS SECTION

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.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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 SECTION

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 SECTION

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

SPL UNCLASSIFIED SECTION

Drug Facts

Active Ingredients:

OTC - ACTIVE INGREDIENT SECTION

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

OTC - PURPOSE SECTION

Mite Symptom Relief

INDICATIONS & USAGE SECTION

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

WARNINGS SECTION

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.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

DOSAGE & ADMINISTRATION SECTION

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 SECTION

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

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Lotion-530Lotion-530Soap-660Soap-660Kit-531Kit-531

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
362d7abb-94e6-4c60-9a58-266894157713Product name120231023
6bd95106-a412-1dad-b9cc-4cb74bfb27ceProduct name220230315
f1e0dc7e-7d61-4625-b6d9-4894927679d7Product name220211025
e4870509-7e28-6f92-f0be-dd3dd889a9cfProduct name520200810
6e9d4a47-c464-b93e-aebc-ad7bffc9c4cdProduct name220190619
444b3e50-f226-46ef-bfca-2e7035d140cdProduct name120190611
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
4073022c-5d5d-48f5-82ed-091ad146a4b2Product name120171211
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
290f523a-f9db-9774-b5a9-e1f908ac1782Product name120150828
9ffbd0ae-0bce-c086-b707-f0da5f8cd7c5Product name120150828
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316
5668b646-cd56-c3c7-bdea-3f6b1a8840dbProduct name120140508
6084a4f4-5437-c9a5-caec-5361ee075a59Product name120140508
684ea482-2e8b-14af-5664-b98f1e402036Product name120140508
810ab97e-f109-f41c-7c83-6a652a9cbf43Product name120140508
87711080-88eb-65c5-b2dd-bf99e700a372Product name120140508
8dbefedf-0a0d-a224-5a3c-66dc9e11c2ddProduct name120140508
90c5639a-61b0-88d6-ddcf-21888e94869aProduct name120140508
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877Product name120140508
b060cc1a-fe47-856b-0b77-4448b5963de8Product name120140508
c6b65c52-69c7-df49-550a-a50c137f6218Product name120140508
ec2149b3-5c6d-5344-f757-c86411073075Product name120140508
ed912195-5da0-0f2f-6f4b-3ef17710cbe3Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
10893-530-04Naturasil Mite B Gone TREATMENT Kit118.3 mL in 1 BOTTLELOTION118.3 mL1 [hp_X] in 118.3mL1
10893-531-02Naturasil Mite B Gone TREATMENT Kit1 in 1 KITKIT11
10893-660-04Naturasil Mite B Gone TREATMENT Kit113.3 g in 1 CARTONSOAP113.3 g6 [hp_X] in 113.3g1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
10893-530NATURASIL MITE B GONE TREATMENT KIT (SULFUR, THUJA OCCIDENTALIS) KIT [NATURE'S INNOVATION, INC.]1Current NDC20240214_21ddffb1-6d71-4460-a79c-90e2d65a2bd3.zip
10893-531NATURASIL MITE B GONE TREATMENT KIT (SULFUR, THUJA OCCIDENTALIS) KIT [NATURE'S INNOVATION, INC.]1Current NDC, 3 package rows20240214_21ddffb1-6d71-4460-a79c-90e2d65a2bd3.zip
10893-660NATURASIL MITE B GONE TREATMENT KIT (SULFUR, THUJA OCCIDENTALIS) KIT [NATURE'S INNOVATION, INC.]1Legacy NDC20240214_21ddffb1-6d71-4460-a79c-90e2d65a2bd3.zip

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 36 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
10893-53110893-531-02
10893-53010893-530-04
10893-66010893-660-04

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 33 matching rows.

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 2 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Naturasil Mite B Gone TREATMENT KitSULFUR, THUJA OCCIDENTALISNature's Innovation, Inc.21ddffb1-6d71-4460-a79c-90e2d65a2bd32024-02-07WarningsExact identifier
ndc (package): 10893-530-04
ndc (package): 10893-660-04
ndc (package): 10893-531-02
ndc (product): 10893-531
ndc11 (package): 10893066004
ndc11 (package): 10893053102
ndc11 (package): 10893053004
spl id: 01e4ab96-f3f2-43fb-8ef2-68806c0116b8
spl set id: 21ddffb1-6d71-4460-a79c-90e2d65a2bd3
Naturasil Mite B GoneSULFURNature's Innovation, Inc.d15c2ac6-f323-41af-adfe-f4c88427ffdb2024-01-18WarningsExact identifier
ndc (package): 10893-530-04
ndc (product): 10893-530
ndc11 (package): 10893053004

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.