EDP INDIGO: Package Insert and Label Information

EDP INDIGO- indigofera tinctoria leaf powder
EDP Inc.

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.

Indigofera Tinctoria Leaf

hair dye

Keep out of reach of children  Do not swallow. In case of accidental ingestion, get medical help or contact a Poison Control Center right away.

Hair dyes in blue color

Warnings
For external use only Do not use on damaged or broken scalp When using this product  Avoid contact with eyes. If contact occurs, rinse eyes thoroughly with water. Stop use and ask doctor if rash or irritation on scalp develops and lasts. Store at room temperature

Directions Mix 10g of the applicator with 40ml of water, then apply on hair evenly. After 60 min, rinse with lukewarm water and cleanse with soap or shampoo. Rinse thoroughly with warm water. (Apply more as you needed.)

Indigofera Tinctoria Whole

EDP INDIGO

EDP INDIGO indigofera tinctoria leaf powder

Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:70434-102 Route of Administration TOPICAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength INDIGOFERA TINCTORIA LEAF (INDIGOFERA TINCTORIA LEAF) INDIGOFERA TINCTORIA LEAF 0.999 in 100 g

Inactive Ingredients Ingredient Name Strength INDIGOFERA TINCTORIA WHOLE 0.001 in 100 g

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:70434-102-02 1 BAG in 1 PACKAGE contains a BAG (70434-102-01) 1 NDC:70434-102-01 100 g in 1 BAG This package is contained within the PACKAGE (70434-102-02)

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved drug other 02/01/2016

Labeler — EDP Inc. (689605985)

Registrant — EDP Inc. (689605985)

Establishment
Name	Address	ID/FEI	Operations
EDP Inc.		689605985	relabel (70434-102)

Establishment
Name	Address	ID/FEI	Operations
Kirpal Export Overseas		862887706	manufacture (70434-102)

Revised: 01/2019 EDP Inc.