HAKU PINEAPPLE HAND SANITIZER- ethyl alcohol gel 
SRC Company 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

Ethyl alcohol 70%

INACTIVE INGREDIENTS

Water, Carbomer, Glycerin, Propylene Glycol, Triethanolamine, Polysorbate 80, Aloe barbadensis leaf extract, Fragrance

PURPOSE

ANTISEPTIC

WARNINGS

For external use only. Flammable. Keep away from heat or flame
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Do not use
• in children less than 2 months of age
• on open skin wounds
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When using this product keep out of eyes, ears, and mouth. In case of contact with eyes, rinse eyes thoroughly with water.
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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

If swallowed, get medical help or contact a Poison Control Center right away.

Uses

• Hand sanitizer to help reduce bacteria that potentially can cause disease.
• Recommended for repeated use.

Directions

• Place enough product on hands to cover all surfaces. Rub hands together until dry.
• Supervise children under 6 years of age when using this product to avoid swallowing.
• Not recommended for infants

Other Information

• Store between 1℃-30℃ (33.8℉-86℉)
• Avoid freezing and excessive heat above 40℃ (104℉)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Image of tube

HAKU PINEAPPLE HAND SANITIZER 
ethyl alcohol gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:78857-060
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL42 mL  in 60 mL
Inactive Ingredients
Ingredient NameStrength
Water (UNII: 059QF0KO0R)  
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)  
Glycerin (UNII: PDC6A3C0OX)  
Propylene Glycol (UNII: 6DC9Q167V3)  
TROLAMINE (UNII: 9O3K93S3TK)  
Polysorbate 80 (UNII: 6OZP39ZG8H)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:78857-060-0160 mL in 1 TUBE; Type 0: Not a Combination Product06/01/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333E06/01/2020
Labeler - SRC Company Co., Ltd. (694702525)
Registrant - SRC Company Co., Ltd. (694702525)
Establishment
NameAddressID/FEIBusiness Operations
C&N COSMETICS CO.,LTD688853696manufacture(78857-060)

Revised: 6/2020
Document Id: fbbec950-2e7b-45d8-ac23-6c7690eb5431
Set id: 26f54d72-ea22-41ff-82d3-5465641c16d3
Version: 1
Effective Time: 20200611
 
SRC Company Co., Ltd.