ROOTHOUSE ENCORE- salicylic acid, dexpanthenol, l-menthol shampoo 
Roothouse

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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Drug Facts

Salicylic Acid, Dexpanthenol, L-Menthol

Water, Dimethicone, Perilla Frutescens Leaf (Perilla Ocymoides Leaf), and Thuja Orientalis Leaf, etc.

Prevent hair loss and increase hair thickness.

Keep out or reach of the children

After getting hairs wet enough with clean water, apply as needed and make some foam from the almost scalp, and then shampoo as if massaging. When there is plenty of foam, leave it as it is 1-2 minutes. After that, wash hairs well with clean water.

1. If rash, flare, itching, and other symptoms are caused by the treatment, then stop using it and contact a medical doctor or a pharmacist.
2. Do not apply on skin regions with damage, eczema and dermatitis.
3. If it goes in the eyes, immediately clean the eyes.
4. Attention in storage

1) Close the lid after use.

2) Keep it away from the touch of young children.

3) Keep out of high temperature, low temperature, and direct sunlight.

For external use only

Label

ROOTHOUSE ENCORE 
salicylic acid, dexpanthenol, l-menthol shampoo
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70652-0001
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ) SALICYLIC ACID0.25 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
PERILLA FRUTESCENS LEAF (UNII: T4L5881Y68)  
DEXPANTHENOL (UNII: 1O6C93RI7Z)  
WATER (UNII: 059QF0KO0R)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
PLATYCLADUS ORIENTALIS LEAF (UNII: 32E5V7G32B)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:70652-0001-1500 mL in 1 BOTTLE; Type 0: Not a Combination Product03/30/2016
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved drug other03/30/2016
Labeler - Roothouse (688709975)
Registrant - Roothouse (688709975)
Establishment
NameAddressID/FEIBusiness Operations
Roothouse688709975manufacture(70652-0001)

Revised: 4/2016
Document Id: 316f56f2-e853-44b3-e054-00144ff8d46c
Set id: 316f56f2-e852-44b3-e054-00144ff8d46c
Version: 1
Effective Time: 20160426
 
Roothouse