Label: ACNE LOTIONSULFUR SULFUR- sulfur lotion
- NDC Code(s): 62742-4169-1
- Packager: Allure Labs 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 November 9, 2018
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- ACTIVE INGREDIENT
- PURPOSE
- INDICATIONS & USAGE
- WARNINGS
- KEEP OUT OF REACH OF CHILDREN
- DOSAGE & ADMINISTRATION
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INACTIVE INGREDIENT
Aqua, Lenolenic Acid, Lenoleic Acid, Glycerine, Soybeen, PEG-6 Caprylic/Capric glycerides, Cetostearyl acohol, Dihexadecyl phosphate, Ceteth-10 phosphate, Dimethicone, Dodecyl gallate, Ethylhexyl gallate, Saw palmetto, Glyceryl monostearate, PEG-100 stearate, Cetyl alcohol, Polyacrylamide, C13- 14 Isoparaffin, Laureth-7, Aloe vera leaf, Phenoxyethanol, Calrylyl Glycol, Ethylhexyl glycerin, Hexylene glycol, Stearic acid, Propylene glycol, Comfrey leaf, Plantago ovata seed, Glutamine, Proline, Leucine, Serine, Trolamine, Green tea leaf, Azadirachta indica leaf, Chamomile, Levender oil, Xantham gum, Alpha-tocopherol acetate, Malva sylvestris extract, Melissa officinalis leaf, Achillea Millefolium, Sodium hyaluronate, Imperata Cylendrica root, Edetate disodium, Magnesium aluminum silicate.
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
ACNE LOTIONSULFUR SULFUR
sulfur lotionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:62742-4169 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Sulfur (UNII: 70FD1KFU70) (Sulfur - UNII:70FD1KFU70) Sulfur 30 mg in 1 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) LINOLENIC ACID (UNII: 0RBV727H71) LINOLEIC ACID (UNII: 9KJL21T0QJ) GLYCERIN (UNII: PDC6A3C0OX) SOYBEAN (UNII: L7HT8F1ZOD) PEG-6 CAPRYLIC/CAPRIC GLYCERIDES (UNII: GO50W2HWO8) CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S) DIHEXADECYL PHOSPHATE (UNII: 2V6E5WN99N) CETETH-10 PHOSPHATE (UNII: 4E05O5N49G) DIMETHICONE (UNII: 92RU3N3Y1O) DODECYL GALLATE (UNII: 45612DY463) ETHYLHEXYL GALLATE (UNII: O14R793D1H) SAW PALMETTO (UNII: J7WWH9M8QS) GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4) PEG-100 STEARATE (UNII: YD01N1999R) CETYL ALCOHOL (UNII: 936JST6JCN) POLYACRYLAMIDE (1500 MW) (UNII: 5D6TC4BRWV) C13-14 ISOPARAFFIN (UNII: E4F12ROE70) LAURETH-7 (UNII: Z95S6G8201) ALOE VERA LEAF (UNII: ZY81Z83H0X) PHENOXYETHANOL (UNII: HIE492ZZ3T) CAPRYLYL GLYCOL (UNII: 00YIU5438U) ETHYLHEXYLGLYCERIN (UNII: 147D247K3P) HEXYLENE GLYCOL (UNII: KEH0A3F75J) STEARIC ACID (UNII: 4ELV7Z65AP) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) COMFREY LEAF (UNII: DG4F8T839X) PLANTAGO OVATA SEED (UNII: UD50RBY30F) GLUTAMINE (UNII: 0RH81L854J) PROLINE (UNII: 9DLQ4CIU6V) LEUCINE (UNII: GMW67QNF9C) SERINE (UNII: 452VLY9402) TROLAMINE (UNII: 9O3K93S3TK) GREEN TEA LEAF (UNII: W2ZU1RY8B0) AZADIRACHTA INDICA LEAF (UNII: HKY915780T) CHAMOMILE (UNII: FGL3685T2X) LAVENDER OIL (UNII: ZBP1YXW0H8) XANTHAN GUM (UNII: TTV12P4NEE) .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) MENTHA PIPERITA LEAF (UNII: A389O33LX6) PRIMULA VERIS (UNII: W6LFQ57E4M) ALCHEMILLA XANTHOCHLORA FLOWERING TOP (UNII: 9M289NKI69) MELISSA OFFICINALIS LEAF (UNII: 50D2ZE9219) ACHILLEA MILLEFOLIUM (UNII: 2FXJ6SW4PK) HYALURONATE SODIUM (UNII: YSE9PPT4TH) IMPERATA CYLINDRICA ROOT (UNII: VYT2JA85NH) EDETATE DISODIUM (UNII: 7FLD91C86K) MAGNESIUM ALUMINUM SILICATE (UNII: 6M3P64V0NC) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:62742-4169-1 55 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product 11/09/2018 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part333D 11/09/2018 Labeler - Allure Labs Inc (926831603) Registrant - Allure Labs Inc (926831603) Establishment Name Address ID/FEI Business Operations Allure Labs Inc 926831603 manufacture(62742-4169)