Label: TULA SKINCARE KEEP IT CLEAR ACNE FOAM CLEANSER liquid
- NDC Code(s): 72296-030-18, 72296-030-50
- 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 December 26, 2022
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- Official Label (Printer Friendly)
- Active Ingredients
- Purpose
- Uses
-
Warnings
For external use only
Using other topical medications at the same time or
immediately following use of this product may increase
dryness or irritation of the skin. If this occurs, only one
medication should be used unless directed by a doctor.When using this product
• avoid contact with the eyes
• if contact occurs, rinse thoroughly with water - Keep out of reach of children
-
Directions
• clean the skin thoroughly before applying this product
• cover the entire 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 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
Aqua/Water/Eau, Sodium Methyl 2-Sulfolaurate, Disodium 2-Sulfolaurate, Disodium Laureth Sulfosuccinate, Lactococcus Ferment Lysate, Melaleuca Alternifolia (Tea Tree) Leaf Oil, Azelaic Acid, Morinda Citrifolia Extract, Glycyrrhiza Glabra (Licorice) Root Extract, Vaccinium Angustifolium (Blueberry) Fruit Extract, Zingiber Officinale (Ginger) Root Extract, Lactic Acid, Hydrolyzed Algin, Glycerin, Citric Acid, Phospholipids, Caprylyl Glycol, Sodium Chloride, Benzoic Acid, Sodium Hydroxide, Sodium Glycolate, Trisodium Dicarboxymethyl Alaninate, Butylene Glycol, Chlorphenesin, Sodium Benzoate, Ethylhexylglycerin, Phenoxyethanol
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INGREDIENTS AND APPEARANCE
TULA SKINCARE KEEP IT CLEAR ACNE FOAM CLEANSER
tula skincare keep it clear acne foam cleanser liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:72296-030 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ) SALICYLIC ACID 2 g in 100 g Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) PROPANEDIOL (UNII: 5965N8W85T) DIMETHICONE (UNII: 92RU3N3Y1O) GLYCERIN (UNII: PDC6A3C0OX) DIMETHYL ISOSORBIDE (UNII: SA6A6V432S) LACTOCOCCUS LACTIS (UNII: F1A0PSN10V) POLYSORBATE 20 (UNII: 7T1F30V5YH) HYDROXYETHYL ACRYLATE/SODIUM ACRYLOYLDIMETHYL TAURATE COPOLYMER (100000 MPA.S AT 1.5%) (UNII: 86FQE96TZ4) NIACINAMIDE (UNII: 25X51I8RD4) ALOE VERA LEAF (UNII: ZY81Z83H0X) AZELAIC ACID (UNII: F2VW3D43YT) .ALPHA.-BISABOLOL, (+)- (UNII: 105S6I733Z) CETEARYL OLIVATE (UNII: 58B69Q84JO) CITRULLUS LANATUS WHOLE (UNII: 3J5I6254YO) CITRUS AURANTIUM FLOWER (UNII: O730ZX2Z83) EPILOBIUM ANGUSTIFOLIUM WHOLE (UNII: C278QS9YBT) LACTIC ACID (UNII: 33X04XA5AT) ORYZA SATIVA WHOLE (UNII: 84IVV0906Z) PHENOXYETHANOL (UNII: HIE492ZZ3T) SACCHARIDE ISOMERATE (UNII: W8K377W98I) SODIUM CHLORIDE (UNII: 451W47IQ8X) SODIUM LACTATE (UNII: TU7HW0W0QT) SORBITAN ISOSTEARATE (UNII: 01S2G2C1E4) SORBITAN OLIVATE (UNII: MDL271E3GR) TRISODIUM ETHYLENEDIAMINE DISUCCINATE (UNII: YA22H34H9Q) ETHYLHEXYLGLYCERIN (UNII: 147D247K3P) XANTHAN GUM (UNII: TTV12P4NEE) BLUEBERRY (UNII: 253RUG1X1A) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:72296-030-18 1 in 1 CARTON 12/26/2022 1 180 g in 1 TUBE; Type 0: Not a Combination Product 2 NDC:72296-030-50 1 in 1 CARTON 12/26/2022 2 50 g in 1 BOTTLE, PUMP; 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 12/26/2022 Labeler - Tula Life LLC (080051358)
