Label: TULA ACNE CLEARING AND TONE CORRECTING GEL liquid
- NDC Code(s): 72296-010-15, 72296-010-30
- 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
Water/Aqua/Eau, Sodium Polyacrylate, Sodium PCA, Glycerin, Polyacrylate Crosspolymer-6, Azelaic Acid, Lactococcus Ferment Lysate, Zinc PCA, Epilobium Angustifolium Flower/Leaf/Stem Extract, Niacinamide, Bisabolol, Allantoin, Sodium Hyaluronate, Lactic Acid, Sodium Benzoate, Sodium Chloride, Sodium Metabisulfite, Ehtylhexylglyceirn, Phenoxyethanol
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INGREDIENTS AND APPEARANCE
TULA ACNE CLEARING AND TONE CORRECTING GEL
tula acne clearing and tone correcting gel liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:72296-010 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) SODIUM POLYACRYLATE (8000 MW) (UNII: 285CYO341L) SODIUM PYRROLIDONE CARBOXYLATE (UNII: 469OTG57A2) GLYCERIN (UNII: PDC6A3C0OX) AZELAIC ACID (UNII: F2VW3D43YT) LACTOCOCCUS LACTIS (UNII: F1A0PSN10V) ZINC (UNII: J41CSQ7QDS) EPILOBIUM ANGUSTIFOLIUM LEAF (UNII: 7NV86426N2) NIACINAMIDE (UNII: 25X51I8RD4) .ALPHA.-BISABOLOL, (+)- (UNII: 105S6I733Z) ALLANTOIN (UNII: 344S277G0Z) LACTIC ACID (UNII: 33X04XA5AT) SODIUM BENZOATE (UNII: OJ245FE5EU) SODIUM CHLORIDE (UNII: 451W47IQ8X) SODIUM METABISULFITE (UNII: 4VON5FNS3C) ETHYLHEXYLGLYCERIN (UNII: 147D247K3P) PHENOXYETHANOL (UNII: HIE492ZZ3T) HYALURONATE SODIUM (UNII: YSE9PPT4TH) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:72296-010-30 1 in 1 CARTON 12/26/2022 1 30 g in 1 TUBE; Type 0: Not a Combination Product 2 NDC:72296-010-15 1 in 1 CARTON 12/26/2022 2 15 g in 1 BOTTLE, PLASTIC; 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)