NATURASIL MITE BE GONE- sulfur cream

Naturasil by

Drug Labeling and Warnings

Naturasil 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: Cleanse skin thoroughly before applying. Cover the affected skin area with cream once per day. If excessive drying of the skin or rash occurs, reduce the application of cream 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

10% SULFUR

Topical Mite and Multi-Purpose Itch Cream

Questions? Comments? 866-371-2499

Mfd. by: Nature’s Innovation, Inc.

5317 Palmero Ct., 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.

Packaging

INGREDIENTS AND APPEARANCE

NATURASIL  MITE BE GONE
sulfur cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 10893-430
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
SULFUR (UNII: 70FD1KFU70) (SULFUR - UNII:70FD1KFU70)	SULFUR	0.1 g  in 100 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: 10893-430-02	60 mL in 1 JAR; Type 0: Not a Combination Product	09/11/2020
2	NDC: 10893-430-04	118.3 mL in 1 JAR; Type 0: Not a Combination Product	09/11/2020
3	NDC: 10893-430-08	236.6 mL in 1 JAR; Type 0: Not a Combination Product	09/11/2020

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

Labeler - Nature's Innovation, Inc (602969854)

Establishment
Name	Address	ID/FEI	Business Operations
Nature's Innovation, Inc		602969854	manufacture(10893-430)