OTC Medication Information: Surface Wipes

SURFACE WIPES- citric acid monohydrate cloth
Southern Chem Industries LLC

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.

  1. Citric Acid
  2. Lemon Grass Extract
  3. Water
  4. Quillaja Saponin (Soap Bark)
  5. Stearic Acid

Active Ingredient(s)

Citric Acid

Purpose

Surface Cleaner

Use

For surface cleaning to decrease bacteria.

Warnings

DO NOT CONSUME

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

Other information

Store in a cool, dry area, out of reach of children

Inactive ingredients

Lemon Grass Estract, Water, Soap Bark (Quillaja Saponin), Stearic Acid.

EPA Excempt Product

This Product is excempt from the EPA Registration under minimal risk pesticide exception FIFRA Section 25c

Directions

Apply as needed to cover area targeted for antimicrobial cleansing application.

Package Label — Principal Display Panel

Package.Label Principal Display Panel
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Package.Label Principal Display Panel
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SURFACE WIPES
citric acid cloth
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:55549-200
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
CITRIC ACID MONOHYDRATE (ANHYDROUS CITRIC ACID) ANHYDROUS CITRIC ACID 0.88 mg in 100 mg
Inactive Ingredients
Ingredient Name Strength
JAMMU LEMONGRASS OIL 1 mg in 100 mg
WATER
QUILLAJA SAPONARIA BARK 0.03 mg in 100 mg
STEARIC ACID 1 mg in 100 mg
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:55549-200-80 400 mg in 1 CANISTER None
2 NDC:55549-200-16 800 mg in 1 CANISTER None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph not final part356 03/30/2020
Labeler — Southern Chem Industries LLC (056025778)
Registrant — Southern Chem Industries LLC (056025778)
Establishment
Name Address ID/FEI Operations
Southern Chem Industries LLC 056025778 manufacture (55549-200)

Revised: 02/2021 Southern Chem Industries LLC

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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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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