CLIXIT ACNE ERASER- sulfur lotion

CliXit Acne Eraser by

Drug Labeling and Warnings

CliXit Acne Eraser by is a Otc medication manufactured, distributed, or labeled by Clixit, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts:

Active Ingredient

Sulfur 10%

Purpose

Acne Treatment

Use For:

For the treatment of acne. Clears up acne pimples and blemishes, and allows skin to heal. Helps prevent new pimples and blemishes from forming.

Warnings:

For external use only. Using other topical acne medications at the same time or immediately following use of this product may increase dryness or irritation of the skin. Because excessive drying of the skin may occur, start with one application daily, then gradually increase to two or three time daily if needed or as directed by a doctor. If bothersome dryness or peeling occurs, reduce application to once per day. Do not use for prolonged periods without consulting a doctor.

Keep out of reach of children.

If swallowed, contact physician or poison control center immediately.

Store at room temperature

Directions:

Clean the skin thoroughly before applying. Apply directly to blemish or affected area. Do not use on broken skin or large parts of the body. For best results use one to three time per day.

Other Ingredients:

Aqua (Deionized Water), Camphor, Cetyl Alcohol, Cucumis Sativus (Cucumber) Extract, Ethylhexylglycerin, Glyceryl Stearate, Glycyrrhiza Glabra (Licorice) Extract, Magnesium Aluminum Silicate, Melaleuca ALternifolia (Tea Tree) Oil, Phenoxyethanol, Propylene Carbonate, Salicylic Acid, SD-Alcohol 40B, Tapioca Starch, Tetrasodium EDTA, Thymus Vulgaris (Thyme) Extract, Zinc Oxide.

Package Labeling:

INGREDIENTS AND APPEARANCE

CLIXIT ACNE ERASER 
sulfur lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 71328-817
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
SULFUR (UNII: 70FD1KFU70) (SULFUR - UNII:70FD1KFU70)	SULFUR	100 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
CETYL ALCOHOL (UNII: 936JST6JCN)
CUCUMBER (UNII: YY7C30VXJT)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
LICORICE (UNII: 61ZBX54883)
MAGNESIUM ALUMINUM SILICATE (UNII: 6M3P64V0NC)
MELALEUCA ALTERNIFOLIA LEAF (UNII: G43C57162K)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
PROPYLENE CARBONATE (UNII: 8D08K3S51E)
SALICYLIC ACID (UNII: O414PZ4LPZ)
STARCH, TAPIOCA (UNII: 24SC3U704I)
EDETATE SODIUM (UNII: MP1J8420LU)
THYME (UNII: CW657OBU4N)
ZINC OXIDE (UNII: SOI2LOH54Z)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 71328-817-02	1 in 1 BOX	03/15/2017
1		2 mL in 1 APPLICATOR; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part333D	03/15/2017

Labeler - Clixit, LLC (014971694)