NATURASIL MITE B GONE- sulfur lotion

Naturasil Mite B Gone by

Drug Labeling and Warnings

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

Drug Details [pdf]

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 before applying. Cover the affected skin area with lotion once per day. If excessive drying of the skin or rash occurs, reduce the application of lotion or discontinue use. To speed relief, we recommend using Mite-B-Gone Sulfur-Lavender Soap. 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

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 and Irritation

Mite-B-Gone Sulfur Mite Lotion is 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 blend works 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 relief fast. Added sunflower oil helps to hydrate and soothe your skin.

Mite-B-Gone gives you lasting relief WITHOUT harsh chemicals and irritation.

Proudly Made with love and care in the USA in our FDA Facility right outside of Atlanta, Georgia.

Questions? Comments? 1-866-371-2499
Mfd. by: Nature’s Innovation, Inc.
5317 Palmero Ct., Buford, GA 30518
Rev01182024

*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.

Packaging

INGREDIENTS AND APPEARANCE

NATURASIL MITE B GONE 
sulfur lotion

Product Information
Product Type	HUMAN OTC DRUG	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	02/01/2024
2	NDC: 10893-530-08	1 in 1 BOX	02/01/2024
2		236.6 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

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

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