baby wipes by Jinhua Huihuang Non-woven Products Co., Ltd. BABY WIPES cloth

baby wipes by

Drug Labeling and Warnings

baby wipes by is a Otc medication manufactured, distributed, or labeled by Jinhua Huihuang Non-woven Products Co., Ltd.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredient(s)

Benzalkonium Chloride

Purpose

Antiseptic

Use

For hand sanitizing that helps reduce bacteria on the skin, recommended for repeated use.

Warnings

• For external use only.
• Highly Flammable - Keep away from fire or flame.

Do not use

• On open skin wounds.

WHEN USING

• Avoid contact with eyes, ears, and mouth. In case of contact with eyes, flush with water.
• Avoid contact with broken skin. Do not inhale or ingest.

STOP USE

Stop use and ask a doctor if skin irritation or rash occurs.

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children. If swallowed, contact a Poison Control Center or a doctor.

Directions

• Wipe hands, discard properly in trash receptacle.
• Supervise children under 6 years of age when using this product to avoid swallowing.

Other information

• Store at room temperature. Do not store above 105℉.
• Do not freeze
• May discolor some fabrics. Harmful to wood finishes and plastics.
• Effective at eliminating more than 99.99% of many common harmful germs and bacteriain as little as 15 seconds.

Inactive ingredients

2-Bromo-2-nitro-1,3-propanediol, Chitosan, Polysorbate 20, Propylene Glycol, Citric Acid, Purified Water.

Package Label - Principal Display Panel

NDC: 54016-005-01 60PCS

NDC: 54016-005-02 1PCS

NDC: 54016-005-03 10PCS

NDC: 54016-005-04 15PCS

NDC: 54016-005-05 20PCS

NDC: 54016-005-06 25PCS

NDC: 54016-005-07 30PCS

NDC: 54016-005-08 40PCS

NDC: 54016-005-09 50PCS

NDC: 54016-005-10 80PCS

NDC: 54016-005-11 90PCS

NDC: 54016-005-12 100PCS

NDC: 54016-005-13 120PCS

NDC: 54016-005-14 150PCS

INGREDIENTS AND APPEARANCE

BABY WIPES 
baby wipes cloth

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 54016-005
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y)	BENZALKONIUM CHLORIDE	0.03 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
BRONOPOL (UNII: 6PU1E16C9W)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
WATER (UNII: 059QF0KO0R)
POLYSORBATE 20 (UNII: 7T1F30V5YH)
POLIGLUSAM (UNII: 82LKS4QV2Y)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 54016-005-01	60 in 1 PACKET	09/09/2020
1		6.85 mL in 1 PATCH; Type 0: Not a Combination Product
2	NDC: 54016-005-02	1 in 1 PACKET	09/09/2020
2		6.85 mL in 1 PATCH; Type 0: Not a Combination Product
3	NDC: 54016-005-03	10 in 1 PACKET	09/09/2020
3		6.85 mL in 1 PATCH; Type 0: Not a Combination Product
4	NDC: 54016-005-04	15 in 1 PACKET	09/09/2020
4		6.85 mL in 1 PATCH; Type 0: Not a Combination Product
5	NDC: 54016-005-05	20 in 1 PACKET	09/09/2020
5		6.85 mL in 1 PATCH; Type 0: Not a Combination Product
6	NDC: 54016-005-06	25 in 1 PACKET	09/09/2020
6		6.85 mL in 1 PATCH; Type 0: Not a Combination Product
7	NDC: 54016-005-07	30 in 1 PACKET	09/09/2020
7		6.85 mL in 1 PATCH; Type 0: Not a Combination Product
8	NDC: 54016-005-08	40 in 1 PACKET	09/09/2020
8		6.85 mL in 1 PATCH; Type 0: Not a Combination Product
9	NDC: 54016-005-09	50 in 1 PACKET	09/09/2020
9		6.85 mL in 1 PATCH; Type 0: Not a Combination Product
10	NDC: 54016-005-10	80 in 1 PACKET	09/09/2020
10		6.85 mL in 1 PATCH; Type 0: Not a Combination Product
11	NDC: 54016-005-11	90 in 1 PACKET	09/09/2020
11		6.85 mL in 1 PATCH; Type 0: Not a Combination Product
12	NDC: 54016-005-12	100 in 1 PACKET	09/09/2020
12		6.85 mL in 1 PATCH; Type 0: Not a Combination Product
13	NDC: 54016-005-13	120 in 1 PACKET	09/09/2020
13		6.85 mL in 1 PATCH; Type 0: Not a Combination Product
14	NDC: 54016-005-14	150 in 1 PACKET	09/09/2020
14		6.85 mL in 1 PATCH; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333E	09/09/2020

Labeler - Jinhua Huihuang Non-woven Products Co., Ltd. (540165729)

Establishment
Name	Address	ID/FEI	Business Operations
Jinhua Huihuang Non-woven Products Co., Ltd.		540165729	manufacture(54016-005)