Label: NATURASIL MITE B GONE TREATMENT KIT- sulfur, thuja occidentalis kit
- NDC Code(s): 10893-530-04, 10893-531-02, 10893-660-04
- Packager: Nature's Innovation, Inc.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: unapproved homeopathic
DISCLAIMER: This homeopathic product has not been evaluated by the Food and Drug Administration for safety or efficacy. FDA is not aware of scientific evidence to support homeopathy as effective.
Drug Label Information
Updated February 7, 2024
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Topical Mite and Multi-Purpose Itch Lotion
- Active Ingredients:
- Purpose
- INDICATIONS & USAGE
- WARNINGS
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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
- Topical Mite and Multi-Purpose Itch Soap
- Active Ingredients:
- Purpose
- INDICATIONS & USAGE
- WARNINGS
- DOSAGE & ADMINISTRATION
-
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.
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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 IrritationGOOD MANUFACTURING PRACTICE
QUALITY PRODUCTCRUELTY FREE
NOT TESTED ON ANIMALSALL 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 LotionShake Well
Clean Area
Cleanse skin before applicationCover Generously
Cover affected area 2-3 times per daySpeedy Relief
Use in conjunction with Mite-B-Gone Sulfur Lavender SoapCold Open
Refrigerate 2-3 hrs before opening for extra cooling reliefMADE IN USA
- Packaging
-
INGREDIENTS AND APPEARANCE
NATURASIL MITE B GONE TREATMENT KIT
sulfur, thuja occidentalis kitProduct 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 lotionProduct 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 soapProduct 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)
