DHC ACNE SPOT THERAPY- sulfur cream

DHC Acne Spot Therapy by

Drug Labeling and Warnings

DHC Acne Spot Therapy by is a Otc medication manufactured, distributed, or labeled by DHC USA Incorporated, ABBE Laboratories, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

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

SPL UNCLASSIFIED SECTION

Distributed by DHC USA Inc.
Mechanicsburg, PA 17055

PRINCIPAL DISPLAY PANEL - 15 g Tube Box

Acne
Spot Therapy

DHC

Acne Treatment
.52 oz. (15 g) Net wt.

INGREDIENTS AND APPEARANCE

DHC ACNE SPOT THERAPY 
sulfur cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 63433-389
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Sulfur (UNII: 70FD1KFU70) (Sulfur - UNII:70FD1KFU70)	Sulfur	6 mg  in 0.2 g

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 63433-389-00	15 g in 1 TUBE; Type 0: Not a Combination Product	01/01/2018

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part333D	01/01/2018

Labeler - DHC USA Incorporated (004087554)

Registrant - ABBE Laboratories, Inc. (781745286)

Establishment
Name	Address	ID/FEI	Business Operations
ABBE Laboratories, Inc.		781745286	MANUFACTURE(63433-389)