TRU AND GEN 75% ALCOHOL WET WIPES- alcohol cloth 
TRU & GEN

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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TRU & GEN ALCOHOL WET WIPES

Active Ingredient

ALCOHOL ---- 75%

Purpose:

Antibacterial

Inactive Ingredients

Water, Sodium benzoate, PEG-60 Hydrogenated Castor Oil, Lavandual Angustifolia (Lavender) Oil, Butylene Glycol, Aloe Vera Leaf Extract, Chamomila Recutita (Matricaria) Flower Extract

Directions for Use

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.

Warnings:

For External use only. Flammable. Keep away from heat or flame.

When using this product:

Keep out of eyes, ears, and mouth.

In case of contact with eyes, rinse eyes thoroughly with water.

Uses:

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

Keep Out of Reach of Children:

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

Other Information:

Store between 15-30C (59-86F)

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

Keep the lid tightly closed

50 Wipes PDP, NDC: 80500-001-01

50 Wipes, NDC: 80500-001-01

50 WIPES PDPPAGE 2

TRU AND GEN 75% ALCOHOL WET WIPES 
alcohol cloth
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:80500-001
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL0.75 
Inactive Ingredients
Ingredient NameStrength
MATRICARIA CHAMOMILLA (UNII: G0R4UBI2ZZ)  
LAVENDER OIL (UNII: ZBP1YXW0H8)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
PEG-60 HYDROGENATED CASTOR OIL (UNII: 02NG325BQG)  
SODIUM BENZOATE (UNII: OJ245FE5EU)  
WATER (UNII: 059QF0KO0R)  
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
HEXYLENE GLYCOL (UNII: KEH0A3F75J)  
ROSEMARY (UNII: IJ67X351P9)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:80500-001-0150 in 1 PACKET; Type 0: Not a Combination Product09/10/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A09/10/2020
Labeler - TRU & GEN (117625864)
Registrant - TRU & GEN (117625864)
Establishment
NameAddressID/FEIBusiness Operations
TRU & GEN LLC117625864pack(80500-001) , label(80500-001)
Establishment
NameAddressID/FEIBusiness Operations
DONGBANG COSMETICS CO., LTD694452564manufacture(80500-001)

Revised: 9/2020
Document Id: aed59330-1f9c-1482-e053-2995a90a2437
Set id: aed59330-1f9b-1482-e053-2995a90a2437
Version: 1
Effective Time: 20200908
 
TRU & GEN