Label: RAPHE PHARMACEUTIQUE PRO VITAMIN B5 BIOTIN- pyrithione zinc liquid
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Contains inactivated NDC Code(s)
NDC Code(s): 82627-002-01 - Packager: AmWiner & Raphe Holdings LLC
- 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 1, 2022
If you are a consumer or patient please visit this version.
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- Active Ingredient
- Purpose
- Uses
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Warnings
For external use only
Ask a doctor before use if condition covers a large area.
When using this product avoid contact with eyes. If contact occurs, rinse eyes thoroughly with water
Stop use and ask a doctor if condition worsens or does not improve after regular use of the product as directed.
Keep out of reach of children. If swallowed, get medical help, or contact a Poison Control Center right away. - KEEP OUT OF REACH OF CHILDREN
- Directions
- Inactive ingredients
- Other information
- Product label
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INGREDIENTS AND APPEARANCE
RAPHE PHARMACEUTIQUE PRO VITAMIN B5 BIOTIN
pyrithione zinc liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:82627-002 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength PYRITHIONE ZINC (UNII: R953O2RHZ5) (PYRITHIONE ZINC - UNII:R953O2RHZ5) PYRITHIONE ZINC 0.1 g in 100 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) PANTHENOL (UNII: WV9CM0O67Z) MINOXIDIL (UNII: 5965120SH1) GREEN TEA LEAF (UNII: W2ZU1RY8B0) BIOTIN (UNII: 6SO6U10H04) FINASTERIDE (UNII: 57GNO57U7G) SAW PALMETTO (UNII: J7WWH9M8QS) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:82627-002-01 60 mL in 1 BOTTLE; Type 0: Not a Combination Product 09/01/2022 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part358H 09/01/2022 Labeler - AmWiner & Raphe Holdings LLC (113433590) Establishment Name Address ID/FEI Business Operations AmWiner & Raphe Holdings LLC 113433590 manufacture(82627-002)