Label: ACNE ALL-STAR 3-IN-1 ACNE CLEANSER, MASK AND SPOT TREATMENT- sulfur lotion liquid
- NDC Code(s): 72296-090-01
- Packager: Tula Life LLC
- 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 July 24, 2022
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- Official Label (Printer Friendly)
- Active Ingredients
- Purpose
- Uses
-
Warnings
For external use only.
When using this product • Skin irritation and dryness is more likely to occur if you use another
topical acne medication at the same time. If irritation occurs, only use one
topical acne medication at a time.Do not use on
• Broken skin
• Large areas of the skin.When using this product
• Apply only to areas with acne
• Avoid contact with the eyes
• If contact occurs, rinse thoroughly with water - Keep out of reach of children
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Directions
• Clean the skin thoroughly before applying this product.
• Cover the entire affected area with a thin layer and rinse thoroughly one
to three times daily.
• Because excessive drying of the skin may occur, start with one
application daily, then increase to two or 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 (AQUA), GLYCERIN, BENTONITE, SODIUM COCOYL ISETHIONATE, PROPANEDIOL, SODIUM COCOYL GLYCINATE, 1,2-HEXANEDIOL, MAGNESIUM ALUMINUM SILICATE, ACACIA SENEGAL GUM, SEA WATER, SALIX ALBA (WILLOW) BARK EXTRACT, LACTOCOCCUS FERMENT LYSATE, LACTOBACILLUS, LACTOBACILLUS FERMENT, CAMELLIA OLEIFERA LEAF EXTRACT, BETULA ALBA BARK EXTRACT, SCROPHULARIA NODOSA EXTRACT, BETULA ALBA JUICE, PINUS DENSIFLORA LEAF EXTRACT, ASPALATHUS LINEARIS LEAF EXTRACT,
PANTHENOL, CURCUMA LONGA (TURMERIC) ROOT EXTRACT, BETA VULGARIS (BEET) ROOT EXTRACT, ALPHA-GLUCAN OLIGOSACCHARIDE, POLYMNIA SONCHIFOLIA ROOT JUICE, INULIN, LACTIC ACID, LEUCONOSTOC/RADISH ROOT FERMENT FILTRATE, ANANAS SATIVUS (PINEAPPLE) FRUIT EXTRACT, CITRUS AURANTIUM DULCIS (ORANGE) FRUIT EXTRACT, CITRUS LIMON (LEMON) PEEL EXTRACT, EUGENIA CARYPHYLLUS (CLOVE) FLOWER EXTRACT, PYRUS COMMUNIS (PEAR) FRUIT EXTRACT, PYRUS MALUS (APPLE) FRUIT EXTRACT, SALVIA OFFICINALIS (SAGE) LEAF EXTRACT, VANILLA PLANIFOLIA FRUIT EXTRACT, SODIUM CHLORIDE, SORBITAN OLEATE DECYLGLUCOSIDE CROSSPOLYMER, MALTODEXTRIN, BUTYLENE GLYCOL, SODIUM BENZOATE, DIPROPYLENE GLYCOL, HYDROXYPROPYL CYCLODEXTRIN, POTASSIUM SORBATE, CITRIC ACID, QUARTZ, CHLOROPHYLLIN-COPPER COMPLEX, SODIUM COCOATE, COCONUT ACID, SODIUM ISETHIONATE, TITANIUM DIOXIDE (CI 77891). - Principal Display Panel
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INGREDIENTS AND APPEARANCE
ACNE ALL-STAR 3-IN-1 ACNE CLEANSER, MASK AND SPOT TREATMENT
sulfur lotion liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:72296-090 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength SULFUR (UNII: 70FD1KFU70) (SULFUR - UNII:70FD1KFU70) SULFUR 0.03 g in 1 g Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) GLYCERIN (UNII: PDC6A3C0OX) BENTONITE (UNII: A3N5ZCN45C) SODIUM COCOYL ISETHIONATE (UNII: 518XTE8493) PROPANEDIOL (UNII: 5965N8W85T) SODIUM COCOYL GLYCINATE (UNII: XLU9KH03XM) 1,2-HEXANEDIOL (UNII: TR046Y3K1G) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) MAGNESIUM ALUMINUM SILICATE (UNII: 6M3P64V0NC) ACACIA (UNII: 5C5403N26O) COCONUT ACID (UNII: 40U37V505D) PANTHENOL (UNII: WV9CM0O67Z) WILLOW BARK (UNII: S883J9JDYX) SODIUM ISETHIONATE (UNII: 3R36J71C17) SODIUM CHLORIDE (UNII: 451W47IQ8X) PINEAPPLE JUICE (UNII: O4KOG0B1KC) ORANGE JUICE (UNII: 5A9KE2L9L3) LEMON PEEL (UNII: 72O054U628) CLOVE (UNII: K48IKT5321) PEAR JUICE (UNII: F214DLA9BE) APPLE JUICE (UNII: 9871T0PD5P) SALVIA OFFICINALIS FLOWERING TOP (UNII: 48JCS720FN) VANILLA PLANIFOLIA SEED (UNII: GKQ4MH0F2E) SODIUM COCOATE (UNII: R1TQH25F4I) BETA VULGARIS (UNII: 4G174V5051) COPPER CHLOROPHYLLIN (UNII: EEM82VOY7C) TURMERIC (UNII: 856YO1Z64F) INULIN (UNII: JOS53KRJ01) MALTODEXTRIN (UNII: 7CVR7L4A2D) LACTIC ACID (UNII: 33X04XA5AT) BUTYLENE GLYCOL (UNII: 3XUS85K0RA) SODIUM BENZOATE (UNII: OJ245FE5EU) LACTOBACILLUS ACIDOPHILUS (UNII: 1PRR1V42V5) DIPROPYLENE GLYCOL (UNII: E107L85C40) CAMELLIA OLEIFERA LEAF (UNII: 5077EL0C60) SCROPHULARIA NODOSA (UNII: 7H443NUB2T) ASPALATHUS LINEARIS LEAF (UNII: H7UGK1GJCU) HYDROXYPROPYL .ALPHA.-CYCLODEXTRIN (UNII: ZFR0T80O4Y) LEUCONOSTOC/RADISH ROOT FERMENT FILTRATE (UNII: D2QHA03458) PINUS DENSIFLORA LEAF (UNII: Q1Q9P50WIY) POTASSIUM SORBATE (UNII: 1VPU26JZZ4) ANHYDROUS CITRIC ACID (UNII: XF417D3PSL) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:72296-090-01 1 in 1 CARTON 07/25/2022 1 113 g in 1 TUBE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part333D 07/25/2022 Labeler - Tula Life LLC (080051358) Registrant - Tula Life LLC (080051358) Establishment Name Address ID/FEI Business Operations Innovation Labs, Inc. 117109069 manufacture(72296-090)