ANTI-BACTERIAL DOUGH gel

ANTI-BACTERIAL DOUGH by

Drug Labeling and Warnings

ANTI-BACTERIAL DOUGH by is a Otc medication manufactured, distributed, or labeled by Dongguan City Dexu Toys Co., Ltd.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredient(s)

Benzalkonium Chloride 0.09%

Purpose

Anti-septic

Use

Anti-bacterial dough helps reduce bacteria that potentially can cause disease.

Read the attached instructions before use.

Warnings

For external use only.
Keep appropriately in container after use.

Do not use

in children less than 3.
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

Stop use and ask a doctor if irritation or rash occurs.
If swallowed, get medical help.

KEEP OUT OF REACH OF CHILDREN

Keep out of eyes , ears , and mouth.

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

Directions

Before use,read the label and the product information.

Place enough in hands and rub hands not less than 1-2 minutes.

Anti-bacterial dough can be used over and over and best within 1 month if kept appropriatelya closed container when not in use.

Other information

Store in room temperature ( 25℃ / 77 ℉ )

Avoid freezing and excessive heat above 70 ℃ ( 158 ℉ )

Inactive ingredients

Whole Wheat Flour , Aqua , Glycerol , Polyvinyl alcohol , Phenoxyethanol , Caprylyl Glycol , Pentylene glycol, Pentasodium Pentetate, Silver Nitrate, Denatonium benzoate, Red 40,Yellow 5, Blue 1, Red 28

Package Label - Principal Display Panel

INGREDIENTS AND APPEARANCE

ANTI-BACTERIAL DOUGH 
anti-bacterial dough gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 78048-016
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y)	BENZALKONIUM CHLORIDE	0.09 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
FD&C RED NO. 40 (UNII: WZB9127XOA)
PENTYLENE GLYCOL (UNII: 50C1307PZG)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
GLYCERIN (UNII: PDC6A3C0OX)
WHEAT (UNII: 4J2I0SN84Y)
WATER (UNII: 059QF0KO0R)
POLYVINYL ALCOHOL, UNSPECIFIED (UNII: 532B59J990)
SILVER NITRATE (UNII: 95IT3W8JZE)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
PENTASODIUM PENTETATE (UNII: 961TOZ5L7T)
D&C RED NO. 28 (UNII: 767IP0Y5NH)
DENATONIUM BENZOATE (UNII: 4YK5Z54AT2)
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)

Product Characteristics
Color		Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 78048-016-01	29 g in 1 BOX; Type 0: Not a Combination Product	12/25/2021
2	NDC: 78048-016-02	57 g in 1 BOX; Type 0: Not a Combination Product	03/30/2021
3	NDC: 78048-016-03	85 g in 1 BOX; Type 0: Not a Combination Product	03/30/2021
4	NDC: 78048-016-04	114 g in 1 BOX; Type 0: Not a Combination Product	03/30/2021
5	NDC: 78048-016-05	142 g in 1 BOX; Type 0: Not a Combination Product	03/30/2021
6	NDC: 78048-016-06	170 g in 1 BOX; Type 0: Not a Combination Product	03/30/2021
7	NDC: 78048-016-07	199 g in 1 BOX; Type 0: Not a Combination Product	03/30/2021
8	NDC: 78048-016-08	227 g in 1 BOX; Type 0: Not a Combination Product	03/30/2021
9	NDC: 78048-016-09	255 g in 1 BOX; Type 0: Not a Combination Product	03/30/2021
10	NDC: 78048-016-10	284 g in 1 BOX; Type 0: Not a Combination Product	03/30/2021

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	03/23/2021

Labeler - Dongguan City Dexu Toys Co., Ltd. (403382659)

Establishment
Name	Address	ID/FEI	Business Operations
Dongguan City Dexu Toys Co., Ltd.		403382659	manufacture(78048-016)