NATURASIL SCABIES- 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]

ACTIVE INGREDIENT

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

Purpose: Scabies Symptom Relief

INDICATIONS & USAGE

Uses:  Symptomatic treatment of scabies

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 area with cream one time per day. If excessive drying of the skin or rash occurs, reduce the application of product or discontinue use. To speed relief, we recommend to use Naturasil Sulfur Lavender Soap. Some individuals may be senstive to sulfur or essential oils. Skin test for tolerability. If irritation or reaction occurs, discontinue use.

INACTIVE INGREDIENT

Inactive Ingredients:  Butyrospermum Parkii (Shea Butter) Fruit, Calendula (Calendula Officinalis) Oil, Cetyl Alcohol, Cetyl Palmitate, Dimethicone, Ethylhexylglycerin, Glycerine, Glyceryl Stearate, Glycine Soja (Soybean) Oil, Melaleuca Alternifolia Leaf, Polysorbate 60, Phenoxyethanol, Purified Water (Aqua), Simmondsia Chinensis (Jojoba) Seed Oil, Stearic Acid. 

QUESTIONS

Questions? Comments? www.naturasil.com 1-866-371-2499 Mfd. by:  Nature's Innovation, Inc. 2723 Brickton North Dr., Buford, GA 30518

PRINCIPAL DISPLAY PANEL

NDC# 10893-420-_

100% Natural

Plant Extracts

Naturasil

__ml

(__ fl. oz.)  Homeopathic Medicine

Scabies Topical Cream

INGREDIENTS AND APPEARANCE

NATURASIL  SCABIES
sulfur cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 10893-420
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 1 mL

Inactive Ingredients
Ingredient Name	Strength
SHEA BUTTER (UNII: K49155WL9Y)
CALENDULA OFFICINALIS FLOWER (UNII: P0M7O4Y7YD)
CETYL ALCOHOL (UNII: 936JST6JCN)
CETYL PALMITATE (UNII: 5ZA2S6B08X)
DIMETHICONE (UNII: 92RU3N3Y1O)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
GLYCERIN (UNII: PDC6A3C0OX)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
SOYBEAN OIL (UNII: 241ATL177A)
MELALEUCA ALTERNIFOLIA LEAF (UNII: G43C57162K)
POLYSORBATE 20 (UNII: 7T1F30V5YH)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
WATER (UNII: 059QF0KO0R)
JOJOBA OIL (UNII: 724GKU717M)
STEARIC ACID (UNII: 4ELV7Z65AP)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 10893-420-04	120 mL in 1 BOTTLE; Type 0: Not a Combination Product	01/11/2012
2	NDC: 10893-420-02	60 mL in 1 BOTTLE; Type 0: Not a Combination Product	01/11/2012	01/01/2019

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved homeopathic		01/11/2012

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

Establishment
Name	Address	ID/FEI	Business Operations
Nature's Innovation, Inc.		602969854	manufacture(10893-420)