SCALP SCALING- biotin, niacinamide, panthenol, zinc pyrithione shampoo 
zaol

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.

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Biotin, Panthenol, Niacinamide, Zinc Pyrithion

Water, Glycerin, Butylene Glycol, etc.

Hair conditioning

Keep out of reach of the children

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 sunlight

2. 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 sunlight

4. Use as avoiding eye areas.

* 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.

  1. Wet hair with lukewarm water to open scalp pores.
  2. 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.
  3. 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.
  4. 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.

For external use only

label

SCALP SCALING 
biotin, niacinamide, panthenol, zinc pyrithione shampoo
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71175-0001
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BIOTIN (UNII: 6SO6U10H04) (BIOTIN - UNII:6SO6U10H04) BIOTIN0.06 g  in 100 mL
NIACINAMIDE (UNII: 25X51I8RD4) (NIACINAMIDE - UNII:25X51I8RD4) NIACINAMIDE0.3 g  in 100 mL
PANTHENOL (UNII: WV9CM0O67Z) (PANTHENOL - UNII:WV9CM0O67Z) PANTHENOL0.5 g  in 100 mL
PYRITHIONE ZINC (UNII: R953O2RHZ5) (PYRITHIONE ZINC - UNII:R953O2RHZ5) PYRITHIONE ZINC1.008 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
WATER (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:71175-0001-1300 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product01/11/2017
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved drug other01/10/2017
Labeler - zaol (689851635)
Registrant - zaol (689851635)
Establishment
NameAddressID/FEIBusiness Operations
zaol689851635manufacture(71175-0001) , pack(71175-0001) , label(71175-0001)

Revised: 1/2017
Document Id: 45cb4131-8464-06dc-e054-00144ff88e88
Set id: 45cb4131-8463-06dc-e054-00144ff88e88
Version: 1
Effective Time: 20170110
 
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