Label: BETTER BRAIDS MEDICATED UN-BRAID MEDICATED- salicylic acid spray
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Contains inactivated NDC Code(s)
NDC Code(s): 58318-004-01 - Packager: Keystone Laboratories
- 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 29, 2016
If you are a consumer or patient please visit this version.
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- Official Label (Printer Friendly)
- ACTIVE INGREDIENT
- PURPOSE
- KEEP OUT OF REACH OF CHILDREN
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DOSAGE & ADMINISTRATION
Directions
Spray generously on hair and massage into scalp.
Style as usual.
For best results use daily or as directed by a doctor.
Vaporisez généreusement sur les cheveux et massez le cuir
chevelu. Coiffez comme à l’habitude.
Pour de meilleurs résultats, utilisez tous les jours ou tel
qu’indiqué par un médecin. -
WARNINGS
WARNINGS
For external use only
Avoid contact with eyes when using this product.
If contact occurs, rinse eyes thoroughly with water.
Stop use and contact a doctor, if condition worsens
or does not improve after regular use of this product as directed.
Keep out of reach of children. If swallowed, get medical
help or contact a Poison Control Center right away.Lors de l’utilisation du produit, évitez tout contact avec
les yeux. S’il y avait contact, rincez les yeux minutieusement
avec de l’eau. Si les conditions s’aggravent ou ne s’améliorent
pas, suite à l’utilisation régulière du produit tel qu’indiqué,
cessez l’utilisation et contactez un médecin.
Gardez hors de la portée des enfants. Si le produit a été
avalé, demandez une aide médicale ou contactez un centre
antipoison immédiatement. - INACTIVE INGREDIENT
- OTHER SAFETY INFORMATION
- INDICATIONS & USAGE
- PRINCIPAL DISPLAY PANEL
-
INGREDIENTS AND APPEARANCE
BETTER BRAIDS MEDICATED UN-BRAID MEDICATED
salicylic acid sprayProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:58318-004 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 mg in 355 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) TRIETHANOLAMINE TRIS(DIHYDROGEN PHOSPHATE) (UNII: 36YHT392ID) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) PRUNUS AMERICANA WHOLE (UNII: G33S0Q958Q) APRICOT KERNEL OIL (UNII: 54JB35T06A) DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4) SIMMONDSIA CHINENSIS LEAF (UNII: 67G221EK95) EDETATE DISODIUM (UNII: 7FLD91C86K) LAVANDULA ANGUSTIFOLIA FLOWER (UNII: 19AH1RAF4M) MENTHA PIPERITA LEAF (UNII: A389O33LX6) FD&C YELLOW NO. 5 (UNII: I753WB2F1M) .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) METHYLPARABEN (UNII: A2I8C7HI9T) PROPYLPARABEN (UNII: Z8IX2SC1OH) GLYCINE (UNII: TE7660XO1C) 2,4,6,8-TETRAMETHYL-2,4,6,8-TETRAVINYLCYCLOTETRASILOXANE (UNII: 3NT606T1VK) GLYCERIN (UNII: PDC6A3C0OX) PEG-75 LANOLIN (UNII: 09179OX7TB) HELIANTHUS ANNUUS FLOWERING TOP (UNII: BKJ0J3D1BP) COCOS NUCIFERA WHOLE (UNII: 245J88W96L) AVOCADO OIL (UNII: 6VNO72PFC1) OLEA EUROPAEA FLOWER (UNII: 498M34P1VZ) OENOTHERA BIENNIS FLOWERING TOP (UNII: I3Z7321G2F) EXT. D&C VIOLET NO. 2 (UNII: G5UX3K0728) POLYQUATERNIUM-6 (15000 MW) (UNII: YFL33X52PX) OCTOXYNOL-9 (UNII: 7JPC6Y25QS) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:58318-004-01 355 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product 09/16/2016 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part358H 09/16/2016 Labeler - Keystone Laboratories (007017429) Establishment Name Address ID/FEI Business Operations Keystone Laboratories Inc. 007017429 manufacture(58318-004)
