Label: SCALP SCALING- biotin, niacinamide, panthenol, zinc pyrithione shampoo
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Contains inactivated NDC Code(s)
NDC Code(s): 71175-0001-1 - Packager: zaol
- Category: HUMAN OTC DRUG LABEL
DISCLAIMER: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.
Drug Label Information
Updated January 10, 2017
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- Official Label (Printer Friendly)
- ACTIVE INGREDIENT
- INACTIVE INGREDIENT
- PURPOSE
- KEEP OUT OF REACH OF CHILDREN
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WARNINGS
1. If the following symptoms occur after product use, stop using the product immediately and consult a dermatologist (continuous use can exacerbate the symptoms).
1) Occurrence of red spots, swelling, itchiness, and other skin irritation
2) If the symptoms above occur after the application area is exposed to direct sunlight2. Do not use on open wounds, eczema, and other skin irritations
3. Precaution for Storage and Handling
1) Close the lid after use
2) Keep out of reach of infants and children
3) Do not to store in a place with high/low temperature and exposed to direct sunlight4. Use as avoiding eye areas.
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INDICATIONS & USAGE
* We recommend a usage depending on one’s scalp type, as follows:
- Oily scalp: morning/evening shampoo (twice a day)
- Neutral scalp: shampoo once a day
- Dry scalp: shampoo once every two days.
- Wet hair with lukewarm water to open scalp pores.
- Pump a sufficient amount of Scalp Scaling Shampoo into hands, apply to scalp and massage gently for 2 minutes to remove sebum and dead skins.
- In massaging like movements, scrub hair & scalp for around 3 minutes before rinsing, to allow absorption of nutrients by scalp.
- To prevent nutrients absorbed by pores from falling out, rinse with water cooler than body temperature.
- Covering scalp with shampoo foam for more than 5 minutes may cause scalp irritability. - Dry hair with blow-dryer using cool air.
- Healthy scalp maintains a sub-acidity state of 4.5-5.5 Ph to protect hair from harmful bacteria. The Scalp Scaling Shampoo balances scalp to a 5.5 Ph, allowing for an optimal and healthy scalp.
- DOSAGE & ADMINISTRATION
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
SCALP SCALING
biotin, niacinamide, panthenol, zinc pyrithione shampooProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:71175-0001 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength BIOTIN (UNII: 6SO6U10H04) (BIOTIN - UNII:6SO6U10H04) BIOTIN 0.06 g in 100 mL NIACINAMIDE (UNII: 25X51I8RD4) (NIACINAMIDE - UNII:25X51I8RD4) NIACINAMIDE 0.3 g in 100 mL PANTHENOL (UNII: WV9CM0O67Z) (PANTHENOL - UNII:WV9CM0O67Z) PANTHENOL 0.5 g in 100 mL PYRITHIONE ZINC (UNII: R953O2RHZ5) (PYRITHIONE ZINC - UNII:R953O2RHZ5) PYRITHIONE ZINC 1.008 g in 100 mL Inactive Ingredients Ingredient Name Strength BUTYLENE GLYCOL (UNII: 3XUS85K0RA) WATER (UNII: 059QF0KO0R) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:71175-0001-1 300 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product 01/11/2017 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved drug other 01/10/2017 Labeler - zaol (689851635) Registrant - zaol (689851635) Establishment Name Address ID/FEI Business Operations zaol 689851635 manufacture(71175-0001) , pack(71175-0001) , label(71175-0001)
