SANCARE POLTONE HAND SANITIZER- alcohol gel 
DONGBANGCOSMETICS 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.

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ACTIVE INGREDIENT

Active ingredients: ALCOHOL 62.0 w%

INACTIVE INGREDIENT

Inactive Ingredients:

Water, Carbomer, Triethanolamine, Polyoxyethylene Hydrogenated Castor Oil, Lavandula Angustifolia (Lavender) Oil, Methylparaben, Butylene Glycol, Hexylene Glycol, Strawberry Extract, Sophora Extract, Mulberry Root Extract, Glycyrrhiza Extract, Grapefruit Extract, Green Tea Extract

PURPOSE

Purpose: SANITIZER

WARNINGS

Warnings:

1. Do not use on the following body parts.
Around the eyes and ears, in the oral cavity, a wide range of body parts and damaged skin (may have irritating effects)

2. If the following symptoms appear, stop using them immediately and consult a doctor or pharmacist.
1) Hypersensitivity symptoms such as rash, erythema, itching, and edema
2) Skin irritation symptoms

3. Other precautions
1) For external use only (do not underwear).
2) Be careful not to get into your eyes, and if so, rinse well with clean water and consult a doctor or pharmacist.
3) Be careful not to inhale vapor when using it extensively or for a long time (if you drink ethanol vapor in large quantities or repeatedly, irritation to the mucous membrane, headache, etc. may occur). (Only for products containing ethanol)
4) When repeated use on the same site, be careful as the skin may become rough due to degreasing.
5) When used in sealed bandages, cast bandages, packs, etc., irritation symptoms may appear.
6) Do not use this medicine for anal or vaginal poultry as it may cause irritation or chemical burns.
7) Do not use for any purpose.

4. Precautions for storage
1) Avoid shading and keep it in shading.
2) Keep it out of reach of children, and if a child swallows it, go to the hospital right away.
3) After use, close the product completely with a lid to prevent the product from drying out or entering foreign objects.
4) Taking it out of the original container and storing it in another container may cause accidents due to misuse or deterioration in quality, so store it in the original container.

KEEP OUT OF REACH OF CHILDREN

Keep it out of reach of children, and if a child swallows it, go to the hospital right away.

Uses

Uses:
Disinfection of hands and skin

Directions

Directions:
Take an appropriate amount on your hands and rub thoroughly to dry.

Other Information

Other Information:
Airtight container, storage at room temperature (1~30°C)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Image of container

SANCARE POLTONE HAND SANITIZER 
alcohol gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:74002-3020
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL124 g  in 200 mL
Inactive Ingredients
Ingredient NameStrength
Water (UNII: 059QF0KO0R)  
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)  
TROLAMINE (UNII: 9O3K93S3TK)  
PEG-60 Hydrogenated Castor Oil (UNII: 02NG325BQG)  
Methylparaben (UNII: A2I8C7HI9T)  
LAVENDER OIL (UNII: ZBP1YXW0H8)  
Butylene Glycol (UNII: 3XUS85K0RA)  
Hexylene Glycol (UNII: KEH0A3F75J)  
BEACH STRAWBERRY (UNII: 98542F2TQS)  
SOPHORA FLAVESCENS ROOT (UNII: IYR6K8KQ5K)  
MORUS ALBA BARK (UNII: 7O71A48NDP)  
GLYCYRRHIZA URALENSIS ROOT (UNII: 42B5YD8F0K)  
GRAPEFRUIT (UNII: O82C39RR8C)  
GREEN TEA LEAF (UNII: W2ZU1RY8B0)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:74002-3020-1200 mL in 1 CONTAINER; Type 0: Not a Combination Product04/01/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333E04/01/2020
Labeler - DONGBANGCOSMETICS CO.,LTD (694452564)
Registrant - DONGBANGCOSMETICS CO.,LTD (694452564)
Establishment
NameAddressID/FEIBusiness Operations
DONGBANGCOSMETICS CO.,LTD694452564manufacture(74002-3020)

Revised: 4/2020
Document Id: 8e94505d-5603-4851-9d09-c1321fbc24af
Set id: 6a671b40-33d7-493e-bdba-f778c25fe9d3
Version: 1
Effective Time: 20200412
 
DONGBANGCOSMETICS CO.,LTD