Label: AL0078101 ALBA BOTANICA GOOD AND CLEAN ACNE WASH- salicylic acid lotion
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Contains inactivated NDC Code(s)
NDC Code(s): 61995-2081-6 - Packager: The Hain Celestial Group, Inc.
- 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 February 5, 2021
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- ACTIVE INGREDIENT
- DOSAGE & ADMINISTRATION
- PURPOSE
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WARNINGS
For external use only. Using other topical acne medications at the same time or immediately following the use of this product may increase dryness and irritation of the skin. If this occurs, only one drug should be used unless directed by a doctor. Avoid direct contact with eyes. If contact occurs, flush throughly with water.
- KEEP OUT OF REACH OF CHILDREN
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INACTIVE INGREDIENT
Water, Glycerin, Lauryl Glucoside, Cocamidopropyl Hydroxysultaine, Sodium Cocoyl Isothionate, Coco-glucosides, Sodium Lauroyl Glutamate, Acer Saccharum (Sugar Maple) Extract, Aloe Barbadensis Leaf Juice(1), Citrus Aurantium Dulcis (Orange) Peel Extract, Citrus Grandis (Grapefruit) Fruit Extract (1), Citrus Limon (Lemon) Fruit Extract, Fragaria Vesca (Strawberry) Fruit Extract (1), Macrocystis Pyrifera Extract, Panax Ginseng Root Extract, Purys Malus (Apple) Extract, Rubus Fruticosus (Blackberry) Fruit Extract, Saccharum Officinarum (Sugar Cane) Extract, Salix Alba (Willow) Bark Extract (1), Vitis Vinifera(Grape) Fruit Extract, Vaccinium Myrtillus Fruit Extract, Citrus Aurantifolia (Lime) Oil (2), Citrus Aurantium Dulcis (Orange) Peel Oil (2), Citrus Grandis (Grapefruit) Peel Oil (2), Citrus Limon (Lemon) Peel Oil (2), Citrus Nobilis (Mandarin Orange) Peel Oil (2), Prunus Amygdalus Dulcis (Sweet Almond) Oil (2), Citric Acid, Decyl Glucoside, Alcohol (1), Sodium Chloride, Phenoxyethanol, Sodium Benzoate, Potassium Sorbate.
(1) Certified Organicf Ingredient; (2) For scent only
- INDICATIONS & USAGE
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
AL0078101 ALBA BOTANICA GOOD AND CLEAN ACNE WASH
salicylic acid lotionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:61995-2081 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ) SALICYLIC ACID 1 g in 100 g Inactive Ingredients Ingredient Name Strength ALPINE STRAWBERRY (UNII: CG6IX3GCMU) MACROCYSTIS PYRIFERA (UNII: K31S3OG5C4) ASIAN GINSENG (UNII: CUQ3A77YXI) APPLE (UNII: B423VGH5S9) SALIX ALBA BARK (UNII: 205MXS71H7) WINE GRAPE (UNII: 3GOV20705G) LEMON (UNII: 24RS0A988O) LAURYL GLUCOSIDE (UNII: 76LN7P7UCU) WATER (UNII: 059QF0KO0R) GLYCERIN (UNII: PDC6A3C0OX) COCO GLUCOSIDE (UNII: ICS790225B) SODIUM LAUROYL GLUTAMATE (UNII: NCX1UU2D33) ACER SACCHARUM BARK/SAP (UNII: Z120VL0KAC) ALOE VERA LEAF (UNII: ZY81Z83H0X) ORANGE (UNII: 5EVU04N5QU) PUMMELO (UNII: ET1TN5W71X) BLACKBERRY (UNII: 8A6OMU3I8L) SUGARCANE (UNII: 81H2R5AOH3) BILBERRY (UNII: 9P2U39H18W) CITRUS MAXIMA FRUIT RIND OIL (UNII: 8U3877WD44) LIME OIL (UNII: UZH29XGA8G) ORANGE OIL (UNII: AKN3KSD11B) LEMON OIL (UNII: I9GRO824LL) MANDARIN OIL (UNII: NJO720F72R) ALMOND OIL (UNII: 66YXD4DKO9) CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) DECYL GLUCOSIDE (UNII: Z17H97EA6Y) GLYCERYL OLEATE (UNII: 4PC054V79P) ALCOHOL (UNII: 3K9958V90M) PHENOXYETHANOL (UNII: HIE492ZZ3T) POTASSIUM SORBATE (UNII: 1VPU26JZZ4) SODIUM BENZOATE (UNII: OJ245FE5EU) SODIUM COCOYL ISETHIONATE (UNII: 518XTE8493) COCAMIDOPROPYL HYDROXYSULTAINE (UNII: 62V75NI93W) SODIUM CHLORIDE (UNII: 451W47IQ8X) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:61995-2081-6 170 g in 1 TUBE; Type 0: Not a Combination Product 11/29/2017 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part333D 11/29/2017 Labeler - The Hain Celestial Group, Inc. (117115556) Registrant - The Hain Celestial Group, Inc. (014334364) Establishment Name Address ID/FEI Business Operations The Hain Celestial Group, Inc. 081512382 manufacture(61995-2081)
