OTC Medication Information: Hair Loss and Scalp Moisturizing

HAIR LOSS AND SCALP MOISTURIZING- palm oil and coconut oil soap
Selenia

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.

ACTIVE INGREDIENT

Active ingredients: PALM OIL 58.1%, COCONUT OIL 24.9%

INACTIVE INGREDIENT

Inactive ingredients: Water, Spices, Houttuyniacordata extract, Dandelion, Licorice, Artemisia herb, Saururuschinensis, Peach kernel, Dried orange peel, Ginkgo nut, Poncirus, Mungbeans, Black nightshade, Rasberry, Aloe

PURPOSE

Purpose: Scalp Conditioning

WARNINGS

Warnings: For external use only Avoid contact with eyes. Discontinue use if signs of irritation or rashes appear. Replace the cap after use. Keep out of reach of children

KEEP OUT OF REACH OF CHILDREN

KEEP OUT OF REACH OF CHILDREN

Uses

Uses:

– prevent hair loss

– helps prevent recurrence of flaking and itching associated with dandruff

Directions

Directions:

1) apply to wet hair shampooing and conditioning by gently massaging onto hair and scalp

2) rinse well

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

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HAIR LOSS AND SCALP MOISTURIZING
palm, coconut soap
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:71946-010
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
PALM OIL (PALM OIL) PALM OIL 61.0 g in 105 g
COCONUT OIL (COCONUT OIL) COCONUT OIL 24.9 g in 105 g
Inactive Ingredients
Ingredient Name Strength
Water
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:71946-010-01 105 g in 1 CARTON None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
unapproved drug other 12/01/2017
Labeler — Selenia (557802784)
Registrant — Selenia (557802784)
Establishment
Name Address ID/FEI Operations
Selenia 557802784 manufacture (71946-010)

Revised: 01/2018 Selenia

Our database comes directly from the FDA’s central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA’s repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

Our database comes directly from the FDA's central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA's repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

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