PPE361 HAND SANITIZER WITH ALOE VERA AND VITAMIN E- ethyl alcohol gel 
ITECH 361 LLC

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.

----------

ITECH361 PPE361 HAND SANITIZER WITH ALOE VERA AND VITAMIN E 100 mL

DRUG FACTS

ACTIVE INGREDIENT

Ethyl Alcohol 75%

PURPOSE

Antiseptic

USES

Hand sanitizer to help reduce bacteria that potentially can cause disease.

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

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

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.

OTHER INFORMATION

■ Store between 15-30C (59-86F)

■ Avoid freezing and excessive heat above 40C (104F)

INACTIVE INGREDIENTS

Water (Aqua), 1,2-Propanediol, Carbomer, Triethanolamine, Fragrance, Aloe Barbadensis Extract, Vitamin E.

QUESTIONS OR COMMENTS?

1-888-405-4442 or visit www.itech361.com.

PPE361 HAND SANITIZER WITH ALOE VERA AND VITAMIN E 100 mL (NDC 74871-102-00)

PPE361 HAND SANITIZER WITH ALOE VERA AND VITAMIN E 100 mL

PPE361 HAND SANITIZER WITH ALOE VERA AND VITAMIN E 
ethyl alcohol gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:74871-102
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL75 mL  in 100 mL
Inactive Ingredients
Ingredient NameStrength
TROLAMINE (UNII: 9O3K93S3TK)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
POLYACRYLIC ACID (8000 MW) (UNII: 73861X4K5F)  
WATER (UNII: 059QF0KO0R)  
FRAGRANCE LAVENDER & CHIA F-153480 (UNII: SXS9CO2TZK)  
TOCOPHEROL (UNII: R0ZB2556P8)  
PROPANEDIOL (UNII: 5965N8W85T)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:74871-102-00100 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product09/25/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A09/25/2020
Labeler - ITECH 361 LLC (859157377)
Registrant - ITECH 361 LLC (859157377)
Establishment
NameAddressID/FEIBusiness Operations
GUANGZHOU GOTDYA FINE CHEMICAL CO LTD551470189manufacture(74871-102)
Establishment
NameAddressID/FEIBusiness Operations
ITECH 361 LLC859157377pack(74871-102)

Revised: 9/2020
Document Id: b066e3b1-b46b-3b31-e053-2a95a90ac2bd
Set id: b066e3b1-b46a-3b31-e053-2a95a90ac2bd
Version: 1
Effective Time: 20200925
 
ITECH 361 LLC