CLEARCALM 3 ANTI-ACNE STARTER- sulfur cream

ClearCalm 3 Anti-Acne Starter by

Drug Labeling and Warnings

ClearCalm 3 Anti-Acne Starter by is a Otc medication manufactured, distributed, or labeled by Ren Ltd.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredients

Sulfur 5%

Purpose

Acne Treatment

Uses

- for treatment of acne

- dries and clears acne pimples, blackheads, and whiteheads

- helps prevent development of new acne pimples, blackheads, and whiteheads

Warnings

For external use only

Ask a doctor or pharmacist before use if you are

using other topical acne medications at the same time or immediately following use of this product.  This may increase dryness or irritation of the skin.  If this occurs, only one medication should be used unless directed by a doctor.

When using this product

do not get into eyes.

Stop use and ask a doctor if

excessive skin irritation develops or increases.

Keep out of reach of children.

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

Directions

- Cleanse the skin thoroughly before applying medication.

- Apply a generous amount onto clean skin over the affected area, avoiding the eye area.

- Leave on for 15 minutes.

- Rinse thoroughly with warm water.

- For best results, use twice a week.

Inactive Ingredients

Alcohol Denat, Benzyl Alcohol, Calcium Carbonate, Camphor, CetearylOlivate, Chamomile Oil, Dehydroacetic Acid, Glucose, Glycerin, Hawthron Stem Extract, Kaolin, Lavender Oil, Licorice Root Extract, Limonene, Linalool, Polysorbate 20, Sage Oil, Sorbitan Olivate, Manuka Oil, Thyme Oil, Water, Willow Bark Extract, Zinc Gluconate, Zinc Oxide

Questions or comments?

Please contact 732-553-1185 from 8:30 - 17:30 EST

DESCRIPTION

SULFUR

LICORICE EXTRACT

ZINC GLUCONATE

WILLOW BARK EXTRACT

CALCIUM CARBONATE

KAOLIN

ESSENTIAL OILS

A treatment mask formulated to combat and help prevent acne.  It will reduce visible blemishes and leave skin looking clear, calm and even toned.

Results: Absorbs sebum and gently exfloiates to decongest acne-causing blocked pores.  Reduces the appearance of pore size and redness.  Soothes and calms.  Lightens the appearance of pigmented acne scars.

REN's ClearCalm 3 system combats the 3 key causes of acne and blemishes: excess sebum: build up of dead skin cells; blemish-causing bacteria.... without harshness.

Skin type
Acne prone skin.  Problem skin prone to breakouts and blemishes

REN CLEAN BIO ACTIVE SKINCARE

NO

PETROCHEMICALS, SULFATES, PARABENS, SYNTHETIC FRAGRANCE, SYNTHETIC COLOURS, T.E.A., D.E.A., GLYCOLS, SILICONES, PEGS, ET AL

SKINCARE AS IT SHOULD BE

DERMATOLOGIST TESTED AND APPROVED REN IS AGAINST ANIMAL TESTING

www.renskincare.com

Manufactured for:
REN Ltd, The Edison,
223-231
Old Marylebone Road,
London NW1 5QT
UK

Distributed by:
REN USA Inc,
250 Kennedy Drive,
Sayreville, New Jersey 08872
USA

Made in the UK

PRINCIPAL DISPLAY PANEL

Product Tube Label

Outer Packaging Label

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

CLEARCALM 3 ANTI-ACNE STARTER 
sulfur cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 51417-3341
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
SULFUR (UNII: 70FD1KFU70) (SULFUR - UNII:70FD1KFU70)	SULFUR	5 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
ALCOHOL (UNII: 3K9958V90M)
BENZYL ALCOHOL (UNII: LKG8494WBH)
CALCIUM CARBONATE (UNII: H0G9379FGK)
CAMPHOR (NATURAL) (UNII: N20HL7Q941)
CHAMOMILE FLOWER OIL (UNII: 60F80Z61A9)
DEHYDROACETIC ACID (UNII: 2KAG279R6R)
GLYCERIN (UNII: PDC6A3C0OX)
KAOLIN (UNII: 24H4NWX5CO)
LAVENDER OIL (UNII: ZBP1YXW0H8)
LINALOOL, (+/-)- (UNII: D81QY6I88E)
POLYSORBATE 20 (UNII: 7T1F30V5YH)
SAGE OIL (UNII: U27K0H1H2O)
SORBITAN OLIVATE (UNII: MDL271E3GR)
MANUKA OIL (UNII: M6QU9ZUH2X)
THYME OIL (UNII: 2UK410MY6B)
WATER (UNII: 059QF0KO0R)
WILLOW BARK (UNII: S883J9JDYX)
ZINC GLUCONATE (UNII: U6WSN5SQ1Z)
ZINC OXIDE (UNII: SOI2LOH54Z)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 51417-3341-1	1 in 1 BOX	02/01/2012
1		14.2 g in 1 BOTTLE; Type 1: Convenience Kit of Co-Package

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part333D	02/01/2012

Labeler - Ren Ltd. (385613831)