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

USES:

Symptomatic treatment of mite infections.

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.

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 Ingredients:

Aqua, Emulsifying Wax, Glycerin (Vegetable), Odor Neutralizer, Potassium Sorbate, Shea Butter, Stearic Acid (Vegetable Derived), Sunflower Seed Oil, Tea Tree Oil, Vitamin E

Questions? Comments?

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SPL UNCLASSIFIED SECTION

Topical Mite and Multi-Purpose Itch Cream

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MADE IN USA

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Mfd. for & Dist. by. Nature's Innovation, Inc. 5317 Palmero Ct., Buford, GA 30518

How To Use:
Start by thoroughly cleansing your skin, then apply a thin layer of cream to the affected area daily. If needed, the cream can be used multiple times a day. If you experience excessive dryness or irritation, reduce the frequency of application or discontinue use.

External Use Only. Ideal for all skin types, but individual sensitivity varies. Test on a small area first. Discontinue use if a reaction occurs and consult a physician. Not suitable for those allergic to sulfur or sulfa-based products.

Remove jewelry before application.

What It Does:

Our product is a natural blend of micronized volcanic sulfur, nourishing essential oils and botanicals that bring quick itch relief from mites, bug bites, acne, seborrheic dermatitis, and eczema, as well as skin discomfort and irritations.

*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.

10% SULFUR

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)
ETHYLENE DISTEARAMIDE (UNII: 603RP8TB9A)
GLYCERIN (UNII: PDC6A3C0OX)
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
SHEA BUTTER (UNII: K49155WL9Y)
STEARIC ACID (UNII: 4ELV7Z65AP)
SUNFLOWER OIL (UNII: 3W1JG795YI)
TEA TREE OIL (UNII: VIF565UC2G)
.ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)

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	10/22/2025
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
4	NDC: 10893-430-03	1 in 1 BOX	10/22/2025
4		60 mL in 1 JAR; 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

Labeler - Nature's Innovation, Inc (602969854)