UTILIDERM ACNE CONTROL- sulfur,resorcinol gel

Utiliderm Acne Control by

Drug Labeling and Warnings

Utiliderm Acne Control by is a Otc medication manufactured, distributed, or labeled by Sante Naturelle (A.G.) Ltee, Delta Pharma Inc, Delta Pharma Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active Ingredients

Sulfur 4%

Resorcinol 2%

PURPOSE

Purpose

acne medication

acne medication

INDICATIONS & USAGE

Use

for the treatment of acne

WARNINGS

Warnings

For external use only

DO NOT USE

Do not use on

■ broken skin ■ large areas of the skin

WHEN USING

When using this product

■ apply only to areas with acne ■ rinse eyes right

away with water if it gets in eyes ■ 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.

STOP USE

Stop use and ask a doctor if skin irritation occurs

or gets worse.

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children. If swallowed, get

medical help or contact Poison Control Center right away.

DOSAGE & ADMINISTRATION

Directions

■ 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.

INFORMATION FOR PATIENTS

Other information

■ keep tightly closed ■ keep away from heat

■ Report serious adverse reaction to:

c/o Report Reaction, LLC, P.O. Box 22,

Plainsboro, New Jersey 08536-0222

INACTIVE INGREDIENT

Inactive ingredients

Benzalkonium chloride, bergamot essential oil,

carbomer U-10, chitosan, Melaleuca alternifolia leaf

essential oil, Nigella sativa seed oil, olive oil, Origanum

vulgare whole plant essential oil, polysorbate 80,

sorbitan.

QUESTIONS

Questions or comments?

Call toll free 1-800-781-7723.

Weekdays from 9 AM - 4 PM, Eastern time.

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

UTILIDERM ACNE CONTROL 
sulfur,resorcinol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 71493-001
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
SULFUR (UNII: 70FD1KFU70) (SULFUR - UNII:70FD1KFU70)	SULFUR	4 mg  in 100 mL
RESORCINOL (UNII: YUL4LO94HK) (RESORCINOL - UNII:YUL4LO94HK)	RESORCINOL	2 mg  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
BERGAMOT OIL (UNII: 39W1PKE3JI)
MELALEUCA ALTERNIFOLIA LEAF (UNII: G43C57162K)
NIGELLA SATIVA SEED OIL (UNII: CS4U38E731)
OLIVE OIL (UNII: 6UYK2W1W1E)
POLYSORBATE 80 (UNII: 6OZP39ZG8H)
SORBITAN (UNII: 6O92ICV9RU)
CHITOSAN MEDIUM MOLECULAR WEIGHT (200-400 MPA.S) (UNII: 5GV09YMO52)
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7)
ORIGANUM VULGARE SUBSP. HIRTUM WHOLE (UNII: 38SNL0F81Z)
CARBOXYPOLYMETHYLENE (UNII: 0A5MM307FC)

Product Characteristics
Color	yellow (light)	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 71493-001-25	1 in 1 CARTON	04/02/2018
1		25 mL 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	04/02/2018

Labeler - Sante Naturelle (A.G.) Ltee (207933979)

Registrant - Delta Pharma Inc (200161730)

Establishment
Name	Address	ID/FEI	Business Operations
Delta Pharma Inc.		200161730	manufacture(71493-001)