UTILIDERM ACNE CONTROL- sulfur,resorcinol gel 
Sante Naturelle (A.G.) Ltee

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Utiliderm Acne Control Gel

Active Ingredients

Sulfur 4%

Resorcinol 2%

Purpose

acne medication

acne medication

Use

for the treatment of acne

Warnings

For external use only

Do not use on

■ broken skin ■ large areas of the skin

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 and ask a doctor if skin irritation occurs

or gets worse.

Keep out of reach of children. If swallowed, get

medical help or contact Poison Control Center right away.

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.

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 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 or comments?

Call toll free 1-800-781-7723.

Weekdays from 9 AM - 4 PM, Eastern time.

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UTILIDERM ACNE CONTROL 
sulfur,resorcinol gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71493-001
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SULFUR (UNII: 70FD1KFU70) (SULFUR - UNII:70FD1KFU70) SULFUR4 mg  in 100 mL
RESORCINOL (UNII: YUL4LO94HK) (RESORCINOL - UNII:YUL4LO94HK) RESORCINOL2 mg  in 100 mL
Inactive Ingredients
Ingredient NameStrength
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
Coloryellow (light) Score    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:71493-001-251 in 1 CARTON04/02/2018
125 mL in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart333D04/02/2018
Labeler - Sante Naturelle (A.G.) Ltee (207933979)
Registrant - Delta Pharma Inc (200161730)
Establishment
NameAddressID/FEIBusiness Operations
Delta Pharma Inc.200161730manufacture(71493-001)

Revised: 3/2018
Document Id: 682e804d-d5bd-c6b4-e053-2a91aa0a25f2
Set id: 682e804d-d5bc-c6b4-e053-2a91aa0a25f2
Version: 1
Effective Time: 20180324
 
Sante Naturelle (A.G.) Ltee