Label: DHC ACNE SPOT THERAPY- sulfur cream
- NDC Code(s): 63433-389-00
- Packager: DHC USA Incorporated
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph final
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.
Drug Label Information
Updated February 28, 2022
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- Official Label (Printer Friendly)
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- Active Ingredient
- Purpose
- Uses
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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.
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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.
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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
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- PRINCIPAL DISPLAY PANEL - 15 g Tube Box
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INGREDIENTS AND APPEARANCE
DHC ACNE SPOT THERAPY
sulfur creamProduct 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)
