TRU AND GEN 75% ALCOHOL WET WIPES- alcohol cloth

TRU AND GEN 75% ALCOHOL WET WIPES by

Drug Labeling and Warnings

TRU AND GEN 75% ALCOHOL WET WIPES by is a Otc medication manufactured, distributed, or labeled by TRU & GEN, TRU & GEN LLC, DONGBANG COSMETICS CO., LTD. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

PRINCIPAL DISPLAY PANEL

50 Wipes PDP, NDC:

80500-001-01

50 Wipes, NDC: 80500-001-01

INGREDIENTS AND APPEARANCE

TRU AND GEN 75% ALCOHOL WET WIPES 
alcohol cloth

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 80500-001
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	0.75

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 80500-001-01	50 in 1 PACKET; Type 0: Not a Combination Product	09/10/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	09/10/2020

Labeler - TRU & GEN (117625864)

Registrant - TRU & GEN (117625864)

Establishment
Name	Address	ID/FEI	Business Operations
TRU & GEN LLC		117625864	pack(80500-001) , label(80500-001)

Establishment
Name	Address	ID/FEI	Business Operations
DONGBANG COSMETICS CO., LTD		694452564	manufacture(80500-001)