OTC Medication Information: Baby Wipes

BABY WIPES- benzalkonium chloride cloth
Jinhua Huihuang Non-woven Products Co., Ltd.

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.

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.
  • 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 and ask a doctor if skin irritation or rash occurs.

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

54016-005-01
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NDC:54016-005-02 1PCS

54016-005-02
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NDC:54016-005-03 10PCS

54016-005-03
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NDC:54016-005-04 15PCS

54016-005-04
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20
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25
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30
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40
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50
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80
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90
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100
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120
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150
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BABY WIPES
baby wipes cloth
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:54016-005
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
BENZALKONIUM CHLORIDE (BENZALKONIUM) BENZALKONIUM CHLORIDE 0.03 g in 100 mL
Inactive Ingredients
Ingredient Name Strength
CITRIC ACID MONOHYDRATE
BRONOPOL
PROPYLENE GLYCOL
WATER
POLYSORBATE 20
POLIGLUSAM
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:54016-005-01 60 PATCH in 1 PACKET contains a PATCH
1 6.85 mL in 1 PATCH This package is contained within the PACKET (54016-005-01)
2 NDC:54016-005-02 1 PATCH in 1 PACKET contains a PATCH
2 6.85 mL in 1 PATCH This package is contained within the PACKET (54016-005-02)
3 NDC:54016-005-03 10 PATCH in 1 PACKET contains a PATCH
3 6.85 mL in 1 PATCH This package is contained within the PACKET (54016-005-03)
4 NDC:54016-005-04 15 PATCH in 1 PACKET contains a PATCH
4 6.85 mL in 1 PATCH This package is contained within the PACKET (54016-005-04)
5 NDC:54016-005-05 20 PATCH in 1 PACKET contains a PATCH
5 6.85 mL in 1 PATCH This package is contained within the PACKET (54016-005-05)
6 NDC:54016-005-06 25 PATCH in 1 PACKET contains a PATCH
6 6.85 mL in 1 PATCH This package is contained within the PACKET (54016-005-06)
7 NDC:54016-005-07 30 PATCH in 1 PACKET contains a PATCH
7 6.85 mL in 1 PATCH This package is contained within the PACKET (54016-005-07)
8 NDC:54016-005-08 40 PATCH in 1 PACKET contains a PATCH
8 6.85 mL in 1 PATCH This package is contained within the PACKET (54016-005-08)
9 NDC:54016-005-09 50 PATCH in 1 PACKET contains a PATCH
9 6.85 mL in 1 PATCH This package is contained within the PACKET (54016-005-09)
10 NDC:54016-005-10 80 PATCH in 1 PACKET contains a PATCH
10 6.85 mL in 1 PATCH This package is contained within the PACKET (54016-005-10)
11 NDC:54016-005-11 90 PATCH in 1 PACKET contains a PATCH
11 6.85 mL in 1 PATCH This package is contained within the PACKET (54016-005-11)
12 NDC:54016-005-12 100 PATCH in 1 PACKET contains a PATCH
12 6.85 mL in 1 PATCH This package is contained within the PACKET (54016-005-12)
13 NDC:54016-005-13 120 PATCH in 1 PACKET contains a PATCH
13 6.85 mL in 1 PATCH This package is contained within the PACKET (54016-005-13)
14 NDC:54016-005-14 150 PATCH in 1 PACKET contains a PATCH
14 6.85 mL in 1 PATCH This package is contained within the PACKET (54016-005-14)
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 Operations
Jinhua Huihuang Non-woven Products Co., Ltd. 540165729 manufacture (54016-005)

Revised: 09/2020 Jinhua Huihuang Non-woven Products Co., Ltd.

Our database comes directly from the FDA’s central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA’s repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

Our database comes directly from the FDA's central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA's repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

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