RENU LABORATORIES ACNE SULPHUR L- acne sulfur lotion suspension

Renu Laboratories Acne Sulphur L by

Drug Labeling and Warnings

Renu Laboratories Acne Sulphur L by is a Otc medication manufactured, distributed, or labeled by Renu Laboratories, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active Ingredient

Sulfur Colloidal (10%)

PURPOSE

Purpose

Topical Acne Treatment

INDICATIONS & USAGE

Uses

• for the treatment of acne
• healing and drying acne breakouts
• helps clear acne pimples, blackheads or whiteheads and allows skin to heal
• penetrates pores to control acne blemishes
• helps keep skin clear of new acne pimples

WARNINGS

Warnings

For external use only

• skin irritation and dryness is more likely to occur if you use another topical acne medication at the same time.
  If irritation occurs, only use one topical acne medication at a time.

DO NOT USE

Do Not Use

• on broken skin
• on large areas of the skin
• if pregnant or breast-feeding, ask a health professional before use.

WHEN USING

When using this product

• apply only to areas with acne

STOP USE

Stop use and ask a doctor if

• excessive dryness or peeling occurs

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children.

If swallowed get medical help or contact a Poison Control Center right away.

DOSAGE & ADMINISTRATION

Directions

• shake well
• clean the skin thoroughly before applying this product
• cover the entire affected area with a thin layer one to three times daily
• 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 a day or every other day

INACTIVE INGREDIENT

Inactive ingredients

Camphor, Iron Oxide, Isopropyl Alcohol, Magnesium Aluminum Silicate, Salicylic Acid, Zinc Oxide.

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

RENU LABORATORIES ACNE SULPHUR L 
acne sulfur lotion suspension

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 76348-450
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
FERRIC OXIDE RED (UNII: 1K09F3G675)
WATER (UNII: 059QF0KO0R)
MAGNESIUM ALUMINUM SILICATE (UNII: 6M3P64V0NC)
ZINC OXIDE (UNII: SOI2LOH54Z)
SALICYLIC ACID (UNII: O414PZ4LPZ)
CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET)
ISOPROPYL ALCOHOL (UNII: ND2M416302)

Product Characteristics
Color	white (Suspension)	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 76348-450-02	56 g in 1 BOTTLE, GLASS; Type 0: Not a Combination Product	04/16/2015

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part333D	04/16/2015

Labeler - Renu Laboratories, Inc. (945739449)

Establishment
Name	Address	ID/FEI	Business Operations
Renu Laboratories, Inc.		945739449	manufacture(76348-450)