DHC ACNE SPOT THERAPY- sulfur cream 
DHC USA Incorporated

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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DHC Acne Spot Therapy

Drug Facts

Active Ingredient

Sulfur 3%

Purpose

Acne treatment

Uses

For the management of acne. Helps clear up acne blemishes.

Warnings

For external use only

  • When using this product skin irritation and dryness is more likely to occur if used with another topical acne medication at the same time. If irritation occurs, only use one topical acne medication at a time.
  • Avoid contact with eyes. If excessive skin irritation develops or increases, discontinue use and consult a doctor.

  • Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Do not use on

  • Broken skin
  • Large areas of the skin

When using this product

  • Apply only to areas with acne

Directions

Cleanse skin thoroughly and tone before applying. Cover the 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 to 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 Ingredients

water, butylene glycol, isononyl isononanoate, cetearyl alcohol, sorbitan stearate, ceteareth-20, phenoxyethanol, sucrose cocoate, xanthan gum, sodium citrate, citric acid, allantoin, disodium EDTA, magnesium ascorbyl phosphate, tocopherol, sodium hydroxide, brassica campestris (rapeseed) seed oil, glycyrrhiza glabra (licorice) root extract, camellia sinensis leaf extract, royal jelly extract, scutellaria baicalensis root extract, houttuynia cordata extract, perilla ocymoides leaf extract, aloe barbadensis leaf extract

Questions or Comments?

800-DHC-CARE (342-2273)
dhccare.com

Distributed by DHC USA Inc.
Mechanicsburg, PA 17050

PRINCIPAL DISPLAY PANEL - 15 g Tube Box

DHC

Acne
Spot Therapy

Acne Treatment

.52 oz. (15 g) Net wt.

PRINCIPAL DISPLAY PANEL - 15 g Tube Box
DHC ACNE SPOT THERAPY 
sulfur cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63433-389
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Sulfur (UNII: 70FD1KFU70) (Sulfur - UNII:70FD1KFU70) Sulfur6 mg  in 0.2 g
Inactive Ingredients
Ingredient NameStrength
Water (UNII: 059QF0KO0R)  
Butylene Glycol (UNII: 3XUS85K0RA)  
Isononyl Isononanoate (UNII: S4V5BS6GCX)  
Cetostearyl Alcohol (UNII: 2DMT128M1S)  
Sorbitan Monostearate (UNII: NVZ4I0H58X)  
Sodium Citrate, Unspecified Form (UNII: 1Q73Q2JULR)  
Citric Acid Monohydrate (UNII: 2968PHW8QP)  
Phenoxyethanol (UNII: HIE492ZZ3T)  
Xanthan Gum (UNII: TTV12P4NEE)  
Allantoin (UNII: 344S277G0Z)  
.Alpha.-Tocopherol (UNII: H4N855PNZ1)  
Brassica Rapa Subsp. Oleifera Oil (UNII: N4G8379626)  
Magnesium Ascorbyl Phosphate (UNII: 0R822556M5)  
Glycyrrhiza Glabra (UNII: 2788Z9758H)  
Royal Jelly (UNII: L497I37F0C)  
Green Tea Leaf (UNII: W2ZU1RY8B0)  
Houttuynia Cordata Flowering Top (UNII: RH041UUZ22)  
Scutellaria Lateriflora Top (UNII: C6CNB75R61)  
Perilla Frutescens Leaf (UNII: T4L5881Y68)  
Aloe Vera Leaf (UNII: ZY81Z83H0X)  
Edetate Disodium (UNII: 7FLD91C86K)  
Sodium Hydroxide (UNII: 55X04QC32I)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:63433-389-0015 g in 1 TUBE; Type 0: Not a Combination Product01/01/2018
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart333D01/01/2018
Labeler - DHC USA Incorporated (004087554)
Registrant - ABBE Laboratories, Inc. (781745286)
Establishment
NameAddressID/FEIBusiness Operations
ABBE Laboratories, Inc.781745286MANUFACTURE(63433-389)

Revised: 2/2022
Document Id: b63c89b8-6c47-414f-92e7-7d91207e9a14
Set id: 84d49048-95cf-4f14-9698-c746237fec9d
Version: 2
Effective Time: 20220228
 
DHC USA Incorporated