Label: YES TO TOMATOES MICELLAR CLEANSING WATER- salicylic acid lotion
Contains inactivated NDC Code(s)
NDC Code(s): 69840-009-09
- Packager: Yes To Incorporated
- 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 June 12, 2017
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- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- Active Ingredients
For external use only
- Avoid contact with the eyes
- If contact occurs, rinse thoroughly with water
- Do not use to clean the eye area.
Before using for the first time, apply a small amount to the affected area for 3 days. If no discomfort occurs, then follow directions for use. Using other topical acne 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.
Cleanse the skin thoroughly before applying medication. 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.
Aloe Barbadensis (Aloe) Leaf Juice, Alcohol Denatured, Water (Aqua), Pentylene Glycol, Polyglyceryl-4 Laurate/Sebacate, Polyglyceryl-4 Caprylate/Caprate, Propandiol, Biosaccharide Gum-1, Caprylyl/Capryl Glucoside, Hamamelis Virginiana (Witch Hazel) Water, Glycerin, Solanum Lycopersicum (Tomato) Fruit Extract, Niacinamide, Disodium EDTA, Sodium Hydroxide, Fragrance (Parfum), Benzyl Benzoate, Coumarin, Butylphenyl Methylpropanal.
PRINCIPAL DISPLAY PANEL - 230 mL Bottle Label
for acne with salicylic acid
Yes to™ fighting pesky pimples
with tomato extract, salicylic acid
and micellar water to gently
cleanse, treat and moisturize
all-in-one, without rinsing.
7.77 fl oz / 230 mL
INGREDIENTS AND APPEARANCE
YES TO TOMATOES MICELLAR CLEANSING WATER
salicylic acid lotion
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:69840-009 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Salicylic Acid (UNII: O414PZ4LPZ) (Salicylic Acid - UNII:O414PZ4LPZ) Salicylic Acid 5 mg in 1 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) Pentylene Glycol (UNII: 50C1307PZG) POLYGLYCERIN-4 (UNII: YX76MGM96B) POLYGLYCERYL-4 CAPRATE (UNII: 3N873UN885) GLYCERIN (UNII: PDC6A3C0OX) Biosaccharide Gum-1 (UNII: BB4PU4V09H) CAPRYLYL/CAPRYL OLIGOGLUCOSIDE (UNII: E00JL9G9K0) WITCH HAZEL (UNII: 101I4J0U34) Niacinamide (UNII: 25X51I8RD4) EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM) PROPANEDIOL (UNII: 5965N8W85T) ALOE VERA LEAF (UNII: ZY81Z83H0X) Alcohol (UNII: 3K9958V90M) SOLANUM LYCOPERSICUM FRUITING TOP (UNII: X636CG4BH0) SODIUM HYDROXIDE (UNII: 55X04QC32I) Product Characteristics Color GRAY (Clear) Score Shape Size Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:69840-009-09 230 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product 06/15/2017 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH FINAL part358H 06/15/2017 Labeler - Yes To Incorporated (788689680) Establishment Name Address ID/FEI Business Operations Emilia Resources Limited 079378421 MANUFACTURE(69840-009)