EFFERVESCENT HAND SANITIZER- benzalkonium chloride tablet

Effervescent Hand Sanitizer by

Drug Labeling and Warnings

Effervescent Hand Sanitizer by is a Otc medication manufactured, distributed, or labeled by Enping Jiaxin Daily Necessities Co., Ltd.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredient(s)

Benzalkonium Chloride 8%. Purpose: Antiseptic

Purpose

Antiseptic, Clean&sanitizing hands

Use

Disposable Effervescent Tablets Hand Sanitizer to help reduce bacteria that potentially can cause disease. For use when soap and water are not available.

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

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.

STOP USE

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

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

Directions

• After dissolution, 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

Sodium Bicarbonate, Citric Acid, Sodium Sulfate, Cetylpyridinium Chloride, PEG-8, Glycerin, Aloe Barbadensis Leaf Extract

Package Label - Principal Display Panel

INGREDIENTS AND APPEARANCE

EFFERVESCENT HAND SANITIZER 
benzalkonium chloride tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 75111-901
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y)	BENZALKONIUM CHLORIDE	8   in 100

Inactive Ingredients
Ingredient Name	Strength
ALOE VERA LEAF (UNII: ZY81Z83H0X)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
SODIUM SULFATE (UNII: 0YPR65R21J)
SODIUM BICARBONATE (UNII: 8MDF5V39QO)
CETYLPYRIDINIUM CHLORIDE (UNII: D9OM4SK49P)
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)
GLYCERIN (UNII: PDC6A3C0OX)

Product Characteristics
Color	yellow, red, purple, green, pink, white, blue	Score	score with uneven pieces
Shape	ROUND	Size	20mm
Flavor	APPLE, ORANGE, LEMON, PEACH, MINT, VANILLA, CITRUS, HONEY, PEPPERMINT, LIME, BERRY, FRUIT, STRAWBERRY, RAISIN, TUTTI FRUTTI, MANGO, MENTHOL, BANANA, BLACKBERRY, BUTTERSCOTCH, COCONUT, BLUEBERRY	Imprint Code	No
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 75111-901-01	1 in 1 BAG; Type 0: Not a Combination Product	03/30/2020
2	NDC: 75111-901-02	8 in 1 BAG; Type 0: Not a Combination Product	03/30/2020
3	NDC: 75111-901-03	10 in 1 BAG; Type 0: Not a Combination Product	03/30/2020
4	NDC: 75111-901-04	12 in 1 BAG; Type 0: Not a Combination Product	03/30/2020
5	NDC: 75111-901-05	15 in 1 BAG; Type 0: Not a Combination Product	03/30/2020
6	NDC: 75111-901-06	20 in 1 BAG; Type 0: Not a Combination Product	03/30/2020
7	NDC: 75111-901-07	30 in 1 BAG; Type 0: Not a Combination Product	03/30/2020
8	NDC: 75111-901-08	36 in 1 BAG; Type 0: Not a Combination Product	03/30/2020
9	NDC: 75111-901-09	50 in 1 BAG; Type 0: Not a Combination Product	03/30/2020
10	NDC: 75111-901-10	100 in 1 BAG; Type 0: Not a Combination Product	03/30/2020
11	NDC: 75111-901-11	8 in 1 BOX; Type 0: Not a Combination Product	03/30/2020
12	NDC: 75111-901-12	10 in 1 BOX; Type 0: Not a Combination Product	03/30/2020
13	NDC: 75111-901-13	12 in 1 BOX; Type 0: Not a Combination Product	03/30/2020
14	NDC: 75111-901-14	15 in 1 BOX; Type 0: Not a Combination Product	03/30/2020
15	NDC: 75111-901-15	20 in 1 BOX; Type 0: Not a Combination Product	03/30/2020
16	NDC: 75111-901-16	30 in 1 BOX; Type 0: Not a Combination Product	03/30/2020
17	NDC: 75111-901-17	36 in 1 BOX; Type 0: Not a Combination Product	03/30/2020
18	NDC: 75111-901-18	50 in 1 BOX; Type 0: Not a Combination Product	03/30/2020
19	NDC: 75111-901-19	100 in 1 BOX; Type 0: Not a Combination Product	03/30/2020
20	NDC: 75111-901-20	400 in 1 BOX; Type 0: Not a Combination Product	03/30/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	03/30/2020

Labeler - Enping Jiaxin Daily Necessities Co., Ltd. (403010421)

Establishment
Name	Address	ID/FEI	Business Operations
Enping Jiaxin Daily Necessities Co., Ltd.		403010421	manufacture(75111-901)