Label: ARCA REGNERATIONSHAMPOO- pinus radiata bark extract, glycerin, menthol, citric acid shampoo
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Contains inactivated NDC Code(s)
NDC Code(s): 83104-401-01 - Packager: Hair Arca, 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 October 4, 2022
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- Active ingredients
- Purpose
- Uses
- Warnings
- Warnings
- Warnings
- Warnings
- Warnings
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Directions
ARCA REGENRATION SHAMPOO recommends the following instructions for scalp improvement and skin troubles.
1 Wet your hair and scalp completely with clean warm water before shampoo
2 Use 1-3 shampoo pumps to massage your scalp and hair.
Then wait 2 to 3 minutes.
3 Rinse thoroughly with warm water.
(Head spa is recommended after hair shampoo use) -
Inactive ingredients
Aqua, Coco-glucoside, Lauryl Glucoside, Sodium Cocoyl Isethionate, Coco-Betaine, Polyquaternium-10, Butylene Glycol, Citric Acid, Sodium Chloride, Lavandula Angustifolia (Lavender) Flower Extract, Monarda Didyma Leaf Extract, Mentha Piperita (Peppermint) Leaf Extract, Freesia Refracta Extract, Chamomilla Recutita (Matricaria) Flower Extract, Rosmarinus Officinalis (Rosemary) Leaf Extract, Pinus Radiata Bark Extract, Panthenol, Sodium Hyaluronate, Polyquaternium-7, coconut fatty acid, Sodium Isethionate, 1,2-Hexandiol 1,2-, Sodium Benzoate, Caprylyl Glycol, Ethylhexylglycerin, Disodium, fragrance, Limonene, Geraniol, Linalool
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INGREDIENTS AND APPEARANCE
ARCA REGNERATIONSHAMPOO
pinus radiata bark extract, glycerin, menthol, citric acid shampooProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:83104-401 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength GLYCERIN (UNII: PDC6A3C0OX) (GLYCERIN - UNII:PDC6A3C0OX) GLYCERIN 2 g in 100 mL MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL 0.5 g in 100 mL PINUS RADIATA BARK (UNII: 6XOU3E49T8) (PINUS RADIATA BARK - UNII:6XOU3E49T8) PINUS RADIATA BARK 0.05 g in 100 mL CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) (ANHYDROUS CITRIC ACID - UNII:XF417D3PSL) ANHYDROUS CITRIC ACID 0.5 g in 100 mL Inactive Ingredients Ingredient Name Strength POLYQUATERNIUM-7 (70/30 ACRYLAMIDE/DADMAC; 1600 KD) (UNII: 0L414VCS5Y) FRAGRANCE LEMON ORC2001060 (UNII: K1725A7G95) FREESIA ALBA FLOWER (UNII: 33X293N6JT) MONARDA DIDYMA LEAF (UNII: JY15982UBB) SODIUM CHLORIDE (UNII: 451W47IQ8X) CHAMOMILE (UNII: FGL3685T2X) SODIUM COCOYL ISETHIONATE (UNII: 518XTE8493) POLYQUATERNIUM-10 (400 CPS AT 2%) (UNII: HB1401PQFS) HYALURONATE SODIUM (UNII: YSE9PPT4TH) LAURYL GLUCOSIDE (UNII: 76LN7P7UCU) COCO GLUCOSIDE (UNII: ICS790225B) COCO-BETAINE (UNII: 03DH2IZ3FY) LAVANDULA ANGUSTIFOLIA FLOWER (UNII: 19AH1RAF4M) SODIUM ISETHIONATE (UNII: 3R36J71C17) 1,2-HEXANEDIOL (UNII: TR046Y3K1G) EDETATE DISODIUM (UNII: 7FLD91C86K) CAPRYLYL GLYCOL (UNII: 00YIU5438U) COCONUT ACID (UNII: 40U37V505D) ETHYLHEXYLGLYCERIN (UNII: 147D247K3P) LIMONENE, (+)- (UNII: GFD7C86Q1W) GERANIOL (UNII: L837108USY) LINALOOL, (+/-)- (UNII: D81QY6I88E) PANTHENOL (UNII: WV9CM0O67Z) WATER (UNII: 059QF0KO0R) BUTYLENE GLYCOL (UNII: 3XUS85K0RA) ROSEMARY (UNII: IJ67X351P9) MENTHA PIPERITA LEAF (UNII: A389O33LX6) SODIUM BENZOATE (UNII: OJ245FE5EU) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:83104-401-01 503 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product 10/04/2022 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final M032 10/04/2022 Labeler - Hair Arca, Inc (106984414) Registrant - Hair Arca, Inc (106984414) Establishment Name Address ID/FEI Business Operations Gopher Co., Ltd. 695650633 manufacture(83104-401)