Olive 75% Marseille: Package Insert and Label Information

OLIVE 75% MARSEILLE — glycerin soap
International Nature Soap Institute

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

glycerine

coconut oil, palm oil, olive oil, sodium hydroxide, water, lavender, etc

skin protectant

keep out of reach of the children

apply to the skin and wash away

・Stop using the product when you have skin problems or the product disagrees with your skin
・Stop using the product immediately and consult a dermatologist if you have redness, swelling, itching or irritation on the skin while or after using the product.
・If the product gets into the eyes, don’t rub but rinse with water.
・Don’t place the product in any place where it will be subjected to extremely high or low temperatures or direct sunlight.

for external use only

OLIVE 75% MARSEILLE glycerin soap

Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:69836-3001 Route of Administration TOPICAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength GLYCERIN (GLYCERIN) GLYCERIN 12 g in 100 g

Inactive Ingredients Ingredient Name Strength WATER NIACINAMIDE SODIUM HYDROXIDE

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:69836-3001-1 100 g in 1 PACKAGE None

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part347 06/17/2015

Labeler — International Nature Soap Institute (689513512)

Registrant — International Nature Soap Institute (689513512)

Establishment
Name	Address	ID/FEI	Operations
International Nature Soap Institute		689513512	manufacture (69836-3001)

Revised: 06/2015 International Nature Soap Institute