Label: TULA SKINCARE GO AWAY ACNE SPOT TREATMENT liquid
- NDC Code(s): 72296-040-15
- 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 31, 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, Dimethyl Isosorbide, Glycerin, Acrylamide/Sodium Acryloyldimethyltaurate Copolymer, Propanediol, Butylene Glycol, Niacinamide, Lactococcus Ferment Lysate, Lactic Acid, Azelaic Acid, Melaleuca Alternifolia (Tea Tree) Leaf Oil, Capryloyl Salicylic Acid, Aloe Barbadensis Leaf Juice, Vaccinium Angustifolium (Blueberry) Fruit Extract, Glycyrrhiza Glabra (Licorice) Root Extract, Zingiber Officinale (Ginger) Root Extract, Citric Acid, Bisabolol, Morinda Citrifolia Extract, Xanthan Gum, Trisodium Ethylenediamine Disuccinate, Tocopherol, 1,2-Hexanediol, Caprylyl Glycol, Carbomer, Silica, Sodium Citrate, Diethylhexyl Sodium Sulfosuccinate, Dimethicone, Ethylhexylglycerin, Hydroxyacetophenone, Isohexadecane, PEG-40 Stearate, Polyglyceryl-2 Isostearate, Polysorbate 80, Potassium Sorbate, Sodium Benzoate, Sodium Chloride, Sodium Hydroxide, Sorbitan Stearate, Phenoxyethanol
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INGREDIENTS AND APPEARANCE
TULA SKINCARE GO AWAY ACNE SPOT TREATMENT
tula skincare go away acne spot treatment liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:72296-040 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength BENZOYL PEROXIDE (UNII: W9WZN9A0GM) (BENZOYL PEROXIDE - UNII:W9WZN9A0GM) BENZOYL PEROXIDE 5 g in 100 g Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) DIMETHYL ISOSORBIDE (UNII: SA6A6V432S) GLYCERIN (UNII: PDC6A3C0OX) PROPANEDIOL (UNII: 5965N8W85T) BUTYLENE GLYCOL (UNII: 3XUS85K0RA) NIACINAMIDE (UNII: 25X51I8RD4) LACTOCOCCUS LACTIS (UNII: F1A0PSN10V) LACTIC ACID (UNII: 33X04XA5AT) AZELAIC ACID (UNII: F2VW3D43YT) MELALEUCA ALTERNIFOLIA LEAF (UNII: G43C57162K) CAPRYLOYL SALICYLIC ACID (UNII: 5F7PJF6AA4) ALOE VERA LEAF (UNII: ZY81Z83H0X) VACCINIUM ANGUSTIFOLIUM LEAF (UNII: B4L873GNG1) GLYCYRRHIZA GLABRA (UNII: 2788Z9758H) ZINGIBER OFFICINALE WHOLE (UNII: IN6Q3S3414) CITRIC ACID ACETATE (UNII: DSO12WL7AU) .ALPHA.-BISABOLOL, (+)- (UNII: 105S6I733Z) MORINDA CITRIFOLIA FRUIT (UNII: 7829X3G2X5) PHENOXYETHANOL (UNII: HIE492ZZ3T) XANTHAN GUM (UNII: TTV12P4NEE) SODIUM CHLORIDE (UNII: 451W47IQ8X) SODIUM HYDROXIDE (UNII: 55X04QC32I) SODIUM BENZOATE (UNII: OJ245FE5EU) SORBITAN OLIVATE (UNII: MDL271E3GR) TRISODIUM ETHYLENEDIAMINE DISUCCINATE (UNII: YA22H34H9Q) ETHYLHEXYLGLYCERIN (UNII: 147D247K3P) TOCOPHEROL (UNII: R0ZB2556P8) 1,2-HEXANEDIOL (UNII: TR046Y3K1G) CARBOMER 940 (UNII: 4Q93RCW27E) SODIUM CITRATE (UNII: 1Q73Q2JULR) DIMETHICONE (UNII: 92RU3N3Y1O) HYDROXYACETOPHENONE (UNII: G1L3HT4CMH) ISOHEXADECANE (UNII: 918X1OUF1E) PEG-40 STEARATE (UNII: ECU18C66Q7) POLYGLYCERYL-2 ISOSTEARATE (UNII: 7B8OE71MQC) POLYSORBATE 80 (UNII: 6OZP39ZG8H) BLUEBERRY (UNII: 253RUG1X1A) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:72296-040-15 1 in 1 CARTON 12/24/2021 1 15 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 12/24/2021 Labeler - Tula Life LLC (080051358)
