Oriental Fermented: Package Insert and Label Information

ORIENTAL FERMENTED — 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, rosemary 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

package label
(click image for full-size original)
ORIENTAL FERMENTED
glycerin soap
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:69836-1001
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
GLYCERIN (GLYCERIN) GLYCERIN 8 g in 100 g
Inactive Ingredients
Ingredient Name Strength
WATER
NIACINAMIDE
SODIUM HYDROXIDE
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:69836-1001-1 100 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 (69836-1001)

Revised: 06/2015 International Nature Soap Institute

DrugInserts.com provides trustworthy package insert and label information about marketed drugs as submitted by manufacturers to the US Food and Drug Administration. Package information is not reviewed or updated separately by DrugInserts.com. Every individual package label entry contains a unique identifier which can be used to secure further details directly from the US National Institutes of Health and/or the FDA.

As the leading independent provider of trustworthy medication information, we source our database directly from the FDA's central repository of drug labels and package inserts under the Structured Product Labeling standard. Our material is not intended as a substitute for direct consultation with a qualified health professional.

Terms of Use | Copyright © 2021. All Rights Reserved.