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

SCALP SCALING by

Drug Labeling and Warnings

SCALP SCALING by is a Otc medication manufactured, distributed, or labeled by zaol. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Biotin, Panthenol, Niacinamide, Zinc Pyrithion

INACTIVE INGREDIENT

Water, Glycerin, Butylene Glycol, etc.

PURPOSE

Hair conditioning

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of the children

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 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.

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.

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.

DOSAGE & ADMINISTRATION

For external use only

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

SCALP SCALING 
biotin, niacinamide, panthenol, zinc pyrithione shampoo

Product 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)