CLEAN ADVANCED HAND SANITIZER: Package Insert and Label Information

CLEAN ADVANCED HAND SANITIZER- alcohol gel
Soky C&T CO.LTD

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: ALCOHOL70% v/v

INACTIVE INGREDIENT

Inactive ingredients:

Water, Carbomer, Aminomethyl Propanol, PEG-60 Hydrogenated Castor Oil, Sodium Hyaluronate, Camellia Sinensis Leaf Extract, Morus Alba Bark Extract, Aloe Barbadensis Leaf Extract, Citrus Limon (Lemon) Peel Oil, Tocopheryl Acetate

PURPOSE

PURPOSE: ANTISEPTIC

WARNINGS

Warnings:

For external use only. Flammable. Keep away from heat or flame
——————————————————————————————————–
Do not use
■ in children less than 2 months of age
■ on open skin wounds
——————————————————————————————————–
When using this product keep out of eyes, ears, and mouth. In case of contact with eyes, rinse eyes thoroughly with water.
——————————————————————————————————–
Stop use and ask a doctor if irritation or rash occurs. These may be signs of a serious condition.

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Uses

Uses

■ hand sanitizer to help reduce bacteria on the skin
■ recommended for repeated use.

Directions

Directions

■ put enough amount onto palm and thoroughly rub until it dries.
■ children under 6 years of age should be supervised when using prosuct.

Other Information

Other Information

■ Store between 15-30C (59-86F)
■ Avoid freezing and excessive heat above 40C (104F)

Package Label : CLEAN ADVANCED HAND SANITIZER 100mL

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

Package Label : CLEAN ADVANCED HAND SANITIZER 500mL

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

CLEAN ADVANCED HAND SANITIZER
alcohol gel
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:76970-020
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Alcohol (ALCOHOL) Alcohol 70 mL in 100 mL
Inactive Ingredients
Ingredient Name Strength
Water
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE
AminomethylPropanol
PEG-60 Hydrogenated Castor Oil
HYALURONATE SODIUM
GREEN TEA LEAF
MORUS ALBA BARK
ALOE VERA LEAF
LEMON OIL
.ALPHA.-TOCOPHEROL ACETATE
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:76970-020-01 100 mL in 1 CONTAINER None
2 NDC:76970-020-02 500 mL in 1 BOTTLE, PUMP None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph not final part333E 04/01/2020
Labeler — Soky C&T CO.LTD (689027803)
Registrant — Soky C&T CO.LTD (689027803)
Establishment
Name Address ID/FEI Operations
Soky C&T CO.LTD 689027803 manufacture (76970-020)

Revised: 05/2020 Soky C&T CO.LTD

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.