CLIXIT ACNE SPOT TREATMENT- sulfur acne treatment ointment

CLIXIT ACNE SPOT TREATMENT by

Drug Labeling and Warnings

CLIXIT ACNE SPOT TREATMENT by is a Otc medication manufactured, distributed, or labeled by Renu Laboratories, Inc., Renu Laboratories, Inc. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active Ingredient

Sulfur 10 percent

PURPOSE

Purpose

Acne Treatment

INDICATIONS & USAGE

Use For

For the treatment of acne

WARNINGS

Warnings

For external use only

Using other topical acne medications at the same time 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 times daily if needed or as directed by a doctor. If bothersome dryness or peeling occurs, reduce application to once per day.

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children.

If swallowed, contact physician or poison control center immediately.

OTHER SAFETY INFORMATION

Store at room temperature

DOSAGE & ADMINISTRATION

Directions

Clean the skin thoroughly before using. Apply directly to blemish or affected area. Do not use on broken skin or large areas of the skin. For best results, use 2-3 times per day.

Do not use on broken skin or large areas of skin.

INACTIVE INGREDIENT

INACTIVE INGREDIENT

Other Ingredients

Camphor, Carbomer, Deionized Water, EDTA (Ethylenediamine Tetraacetic Acid), Ethanol, Ethylhexylglycerin, Phenoxyethanol, Propylene Carbonate, Salicylic Acid, Triethanolamine (TEA)

INACTIVE INGREDIENT

Other Ingredients

Camphor, Carbomer, Deionized Water, EDTA (Ethylenediamine Tetraacetic Acid), Ethanol, Ethylhexylglycerin, Phenoxyethanol, Propylene Carbonate, Salicylic Acid, Triethanolamine (TEA)

QUESTIONS

QUESTIONS

Call 844 425 4948

STATEMENT OF IDENTITY

ACNE SPOT TREATMENT

WITH 10 percent sulfur

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

CLIXIT ACNE SPOT TREATMENT 
sulfur acne treatment ointment

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 76348-446
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
SULFUR (UNII: 70FD1KFU70) (SULFUR - UNII:70FD1KFU70)	SULFUR	1.4 g  in 14 g

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
CAMPHOR (NATURAL) (UNII: N20HL7Q941)
EDETIC ACID (UNII: 9G34HU7RV0)
CARBOMER 980 (UNII: 4Q93RCW27E)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
PROPYLENE CARBONATE (UNII: 8D08K3S51E)
ALCOHOL (UNII: 3K9958V90M)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
TROLAMINE (UNII: 9O3K93S3TK)
SALICYLIC ACID (UNII: O414PZ4LPZ)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 76348-446-02	1 in 1 BOX	10/03/2019
1	NDC: 76348-446-01	14 g in 1 TUBE; 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	10/02/2019

Labeler - Renu Laboratories, Inc. (945739449)

Establishment
Name	Address	ID/FEI	Business Operations
Renu Laboratories, Inc		945739449	manufacture(76348-446)