BETTER BRAIDS MEDICATED UN-BRAID MEDICATED- salicylic acid spray

Better Braids Medicated Un-Braid by

Drug Labeling and Warnings

Better Braids Medicated Un-Braid by is a Otc medication manufactured, distributed, or labeled by Keystone Laboratories, Keystone Laboratories Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active Ingredient: Salicylic Acid

PURPOSE

Anti - dandruff

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children

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

Inactive ingredients

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

OTHER SAFETY INFORMATION

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

INDICATIONS & USAGE

Usage
Reduce frizz, breakage and itching

Utilitè
Réduit les frisottis, les cassures et les demangéaisons.

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

BETTER BRAIDS MEDICATED UN-BRAID  MEDICATED
salicylic acid spray

Product 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)