BETTER BRAIDS MEDICATED UN-BRAID MEDICATED- salicylic acid spray 
Keystone Laboratories

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.

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Active Ingredient: Salicylic Acid

Anti - dandruff

Keep out of reach of children

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

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 ingredients

Aqua/Water/Eau, Glycerin (vegetable),
Triethanolamine, Octoxynol-9, Polyquaternium-6, Propylene Glycol,
Diazolidinyl Urea, Methylparaben, Propylparaben, Disodium EDTA,
Cyclotetrasiloxane, Parfum (Fragrance)


Other Information / Autres informations
Protect this product in this container from excessive heat and
direct sun. For expiration date, please see bottom of bottle.


Usage
Reduce frizz, breakage and itching

Utilitè
Réduit les frisottis, les cassures et les demangéaisons.

label

BETTER BRAIDS MEDICATED UN-BRAID  MEDICATED
salicylic acid spray
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58318-004
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ) SALICYLIC ACID2 mg  in 355 mL
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:58318-004-01355 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product09/16/2016
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart358H09/16/2016
Labeler - Keystone Laboratories (007017429)
Establishment
NameAddressID/FEIBusiness Operations
Keystone Laboratories Inc.007017429manufacture(58318-004)

Revised: 9/2016
Document Id: 3daa3476-f1b2-7323-e054-00144ff8d46c
Set id: 3ca1d25f-aca7-195d-e054-00144ff8d46c
Version: 6
Effective Time: 20160929
 
Keystone Laboratories