Label: BLEMISH VANISHING- salicylic acid gel
- NDC Code(s): 55560-1810-1
- Packager: Andalou naturals
- 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 September 5, 2019
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- Official Label (Printer Friendly)
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- Active Ingredient
- Purpose
- Uses
- Warnings
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Directions
- Clean the skin thoroughly before applying this product.
- Cover the affected area with a thin layer 1-3 times daily.
- Because excessive drying of the skin may occur, start with one application daily, then gradually increase to 2-3 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.
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Inactive Ingredients
Aloe Barbadensis Leaf Juice1, Purified Water (Aqua), Vegetable Glycerin, Ethyl Alcohol1, Hamamelis Virginiana (Witch Hazel) Distillate1, Fruit Stem Cells (Argan, Malus Domestica, Solar Vitis) and BioActive Berry Complex1, Hydroxyethyl Cellulose, Salix Alba (Willow Bark) Extract1, Spiraea Ulmaria (Meadowsweet) Extract1, Epilobium Angustifolium (Willow Herb) Extract, Magnesium Ascorbyl Phosphate (Vitamin C), Zinc Gluconate, Camellia Sinensis (White Tea) Leaf Extract12, Tocopherol, Arnica Montana Flower Extract, Lavandula Officinalis (Lavender) Flower Extract1, Chamomilla Recutita (Chamomile) Flower Extract1, Calendula Officinalis Flower Extract1, Cinnamomum Camphora (Camphor) Bark Oil, Mentha Piperita (Peppermint) Leaf Oil1, Thymus Vulgaris (Thyme) Oil1
- Questions
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- PRINCIPAL DISPLAY PANEL - 18 mL Tube Carton
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INGREDIENTS AND APPEARANCE
BLEMISH VANISHING
salicylic acid gelProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:55560-1810 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ) SALICYLIC ACID 20 mg in 1 mL Inactive Ingredients Ingredient Name Strength ALOE VERA LEAF (UNII: ZY81Z83H0X) WATER (UNII: 059QF0KO0R) GLYCERIN (UNII: PDC6A3C0OX) ALCOHOL (UNII: 3K9958V90M) WITCH HAZEL (UNII: 101I4J0U34) ARGANIA SPINOSA SEED (UNII: 8H7X7XB54H) APPLE (UNII: B423VGH5S9) VITIS VINIFERA SEED (UNII: C34U15ICXA) ACAI (UNII: 46AM2VJ0AW) ARONIA MELANOCARPA FRUIT JUICE (UNII: D2EVP827PJ) ARCTOSTAPHYLOS UVA-URSI LEAF (UNII: 3M5V3D1X36) VACCINIUM MYRTILLUS ANTHOCYANOSIDES (UNII: R911H793SU) EUROPEAN ELDERBERRY JUICE (UNII: Z4IFJ0AK1E) LYCIUM BARBARUM FRUIT (UNII: 930626MWDL) ROSA CANINA FRUIT (UNII: 3TNW8D08V3) HIPPOPHAE RHAMNOIDES FRUIT (UNII: AVL0R9111T) HYDROXYETHYL CELLULOSE (100 MPA.S AT 2%) (UNII: R33S7TK2EP) WILLOW BARK (UNII: S883J9JDYX) FILIPENDULA ULMARIA FLOWER (UNII: 06L18L32G6) EPILOBIUM ANGUSTIFOLIUM FLOWERING TOP (UNII: 08H094218D) MAGNESIUM ASCORBYL PHOSPHATE (UNII: 0R822556M5) ZINC GLUCONATE (UNII: U6WSN5SQ1Z) WHITE TEA (UNII: O0M3396E09) TOCOPHEROL (UNII: R0ZB2556P8) ARNICA MONTANA FLOWER (UNII: OZ0E5Y15PZ) LAVANDULA ANGUSTIFOLIA SUBSP. ANGUSTIFOLIA FLOWER (UNII: 19AH1RAF4M) CHAMOMILE (UNII: FGL3685T2X) CALENDULA OFFICINALIS FLOWER (UNII: P0M7O4Y7YD) CAMPHOR OIL, WHITE (UNII: 26P3H26Z9X) PEPPERMINT OIL (UNII: AV092KU4JH) THYME OIL (UNII: 2UK410MY6B) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:55560-1810-1 1 in 1 CARTON 03/01/2011 1 18 mL 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 03/01/2011 Labeler - Andalou naturals (011472720) Establishment Name Address ID/FEI Business Operations Sun Deep Inc 189788201 MANUFACTURE(55560-1810)
