Rotaniboc Alcohol Prep Pads

Alcohol Prep Pad by

Drug Labeling and Warnings

Alcohol Prep Pad by is a Otc medication manufactured, distributed, or labeled by RTB MED LLC, Wuhan Zonsen Medical Product Co., Ltd.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ALCOHOL PREP PAD- isopropyl alcohol 70% swab 
RTB MED 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.

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Rotaniboc Alcohol Prep Pads

Drug Facts

Active Ingredient

Isopropyl Alcohol 70%

Purpose

Antiseptic

Uses

For preparation of the skin prior to injection.

Warnings

For external use only.

Keep away from fire or flame.

Do not use

  • With electrocautery procedures
  • in the eyes, if contact occurs flush with water

Stop use

  • if irritation and redness develops
  • if condition continues consult your health care practicioner.

Keep out of reach of children. If swallowed, get medical help or contact a poison control center right away.

Directions

  • wipe injection area and discard after single use

Other Information

store at room temperature (15-30C) (59-89F).

Inactive Ingredients

Purified Water

PDP

ALCOHOL PREP PAD 
isopropyl alcohol 70% swab
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 80612-001
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ISOPROPYL ALCOHOL (UNII: ND2M416302) (ISOPROPYL ALCOHOL - UNII:ND2M416302) ISOPROPYL ALCOHOL0.7 mL  in 1 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 80612-001-01200 in 1 BOX09/25/202009/25/2020
11 mL in 1 POUCH; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333E09/25/202009/25/2020
Labeler - RTB MED LLC (124585044)
Establishment
NameAddressID/FEIBusiness Operations
RTB MED LLC124585044relabel(80612-001)
Establishment
NameAddressID/FEIBusiness Operations
Wuhan Zonsen Medical Product Co., Ltd.554474517manufacture(80612-001)

Revised: 12/2021
Document Id: d24204d1-8515-0e67-e053-2a95a90a35a3
Set id: b02a5964-ea82-18e3-e053-2a95a90afd77
Version: 4
Effective Time: 20211203
 
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