Label: ALBA BOTANICA FAST FIX FOR PIMPLE- sulfur cream
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Contains inactivated NDC Code(s)
NDC Code(s): 61995-2796-1 - Packager: The Hain Celestial Group, Inc.
- 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 5, 2021
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- ACTIVE INGREDIENT
- DOSAGE & ADMINISTRATION
- PURPOSE
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WARNINGS
For external use only. Using other topical acne medications at the same time or immediately following the use of this product may increase dryness and irritation of the skin. If this occurs, only one drug should be used unless directed by a doctor. Avoid direct contact with eyes. If contact occurs, flush throughly with water.
- KEEP OUT OF REACH OF CHILDREN
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INACTIVE INGREDIENT
Water, Isoamyl Laurate, Caprylic/Capric Triglyceride, Titanium Dioxide (CI77891), Glyceryl Stearate SE, Glycyrrhiza Glabra (Licorice) Root Extract, Salix Alba (Willow) Bark Extract (1), Alcohol (1), Alumina, Stearyl Alcohol, Cetyl Alcohol, Citric Acid, Glycerin, Jojoba Ester, Saccharomyces Ferment, Silica, Benzyl Alcohol, Potassium Sorbate, Sodium Benzoate, Iron Oxides (CI77491).
(1) Certified Organicf Ingredient;
- INDICATIONS & USAGE
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
ALBA BOTANICA FAST FIX FOR PIMPLE
sulfur creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:61995-2796 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength SULFUR (UNII: 70FD1KFU70) (SULFUR - UNII:70FD1KFU70) SULFUR 6 g in 100 g Inactive Ingredients Ingredient Name Strength SILICON DIOXIDE (UNII: ETJ7Z6XBU4) POTASSIUM SORBATE (UNII: 1VPU26JZZ4) GLYCYRRHIZA GLABRA (UNII: 2788Z9758H) SALIX ALBA BARK (UNII: 205MXS71H7) WATER (UNII: 059QF0KO0R) GLYCERIN (UNII: PDC6A3C0OX) MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U) CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S) ANHYDROUS CITRIC ACID (UNII: XF417D3PSL) SODIUM BENZOATE (UNII: OJ245FE5EU) SACCHAROMYCES LYSATE (UNII: R85W246Z1C) BROWN IRON OXIDE (UNII: 1N032N7MFO) ISOAMYL LAURATE (UNII: M1SLX00M3M) SORBITOL (UNII: 506T60A25R) ALCOHOL (UNII: 3K9958V90M) ALUMINUM OXIDE (UNII: LMI26O6933) JOJOBA OIL, RANDOMIZED (UNII: 7F0EV20QYL) BENZYL ALCOHOL (UNII: LKG8494WBH) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) GLYCERYL STEARATE SE (UNII: FCZ5MH785I) CETYL ALCOHOL (UNII: 936JST6JCN) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:61995-2796-1 30 g in 1 PACKET; Type 0: Not a Combination Product 01/21/2016 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part333D 01/21/2016 Labeler - The Hain Celestial Group, Inc. (117115556) Registrant - The Hain Celestial Group, Inc. (014334364) Establishment Name Address ID/FEI Business Operations The Hain Celestial Group, Inc. 081512382 manufacture(61995-2796)