Label: ALBA ACNEDOTE INVISIBLE TREATMENT- salicylic acid lotion
- NDC Code(s): 61995-2764-1
- 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 December 1, 2022
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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, Alcohol, Aloe Barbadensis Leaf Juice(1), Hamamelis Verginiana (Witch Hazel) Water, Hydroxyethylcellulose, Spiraea Ulmaria Extract, Lens Esculenta (Lentil) Fruit Extract, Arnica Montana (Flower) Extract (1), Camellia Sinensis Leaf Extract (1), Chamomilla Recutita (Matricaria) Flower Extract (1), Calendula Officinalis Flower Extract (1), Lavandula Angustifolia (Lavender) Extract (1), Glycyrrhiza Glabra (Licorice) Rhizome/Root, Salix Alba (Willow) Bark Extract (1),Citrus Aurantium Dulcis (Orange) Peel Oil (2), Citrus Aurantium Bergamia (Bergamot) Oil (2), Mentha Piperita (Peppermint) Oil (2)
(1) Certified Organicf Ingredient; (2) Natural Fragrance
- INDICATIONS & USAGE
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
ALBA ACNEDOTE INVISIBLE TREATMENT
salicylic acid lotionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:61995-2764 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 GLYCYRRHIZA GLABRA (UNII: 2788Z9758H) BERGAMOT OIL (UNII: 39W1PKE3JI) SALIX ALBA BARK (UNII: 205MXS71H7) WATER (UNII: 059QF0KO0R) GLYCERIN (UNII: PDC6A3C0OX) ALOE VERA LEAF (UNII: ZY81Z83H0X) ORANGE OIL (UNII: AKN3KSD11B) ALCOHOL (UNII: 3K9958V90M) HAMAMELIS VIRGINIANA TOP WATER (UNII: NT00Y05A2V) HYDROXYETHYL CELLULOSE (100 MPA.S AT 2%) (UNII: R33S7TK2EP) FILIPENDULA ULMARIA FLOWER (UNII: 06L18L32G6) LENS CULINARIS FRUIT (UNII: ZYZ076G9JH) ARNICA MONTANA FLOWER (UNII: OZ0E5Y15PZ) GREEN TEA LEAF (UNII: W2ZU1RY8B0) CALENDULA OFFICINALIS FLOWER (UNII: P0M7O4Y7YD) PEPPERMINT OIL (UNII: AV092KU4JH) CHAMOMILE FLOWER OIL (UNII: 60F80Z61A9) LAVANDULA ANGUSTIFOLIA FLOWERING TOP (UNII: 9YT4B71U8P) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:61995-2764-1 1 in 1 CARTON 10/01/2013 1 14 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 10/01/2013 Labeler - The Hain Celestial Group, Inc. (117115556) Registrant - The Hain Celestial Group, Inc. (081512382) Establishment Name Address ID/FEI Business Operations The Hain Celestial Group, Inc. 081512382 manufacture(61995-2764)
