Huangjisoo Hand Clean: Package Insert and Label Information

HUANGJISOO HAND CLEAN- alcohol gel
Newfeel

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.

ACTIVE INGREDIENT

Active ingredients: ALCOHOL 62.00%

INACTIVE INGREDIENT

Inactive ingredients:
Water, Glycerin, Carbomer, 1,2-Hexanediol, Apium Graveolens (Celery) Extract, Daucus Carota Sativa (Carrot) Root Extract, Foeniculum Vulgare (Fennel) Seed Extract, Brassica Oleracea Acephala Leaf Extract, Coriandrum Sativum (Coriander) Extract, Lactuca Scariola Sativa (Lettuce) Leaf Extract, Spinacia Oleracea (Spinach) Leaf Extract

PURPOSE

Purpose: SANITIZER

WARNINGS

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

KEEP OUT OF REACH OF CHILDREN

KEEP OUT OF REACH OF CHILDREN

Uses

Uses:
■ for handwashing to decrease the bacteria on the skin
■ recommended for repeated use

Directions

Directions: Rub a dime sized drop into hands.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Image of bottle
(click image for full-size original)

HUANGJISOO HAND CLEAN
alcohol gel
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:73713-010
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ALCOHOL (ALCOHOL) ALCOHOL 310 g in 500 mL
Inactive Ingredients
Ingredient Name Strength
Water
Glycerin
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:73713-010-01 500 mL in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph not final part333E 03/01/2020
Labeler — Newfeel (690062383)
Registrant — Newfeel (690062383)
Establishment
Name Address ID/FEI Operations
Cosmax, Inc. 689049693 manufacture (73713-010)

Revised: 03/2020 Newfeel

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