ALCOHOL PREP PAD- isopropyl alcohol swab 
Tongzhou Ruihong Medical Products Factory

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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Drug Facts

Active Ingredient

Isopropyl Alcohol 70%

Purpose

Antiseptic

Use

For preparation of skin prior to injection prior to injection and to decrease germs in minor cuts and scrapes,

Warnning

For External use only.

Stop use and ask a doctor if irritation develops.

Keep out of reach of children  except with adult supervision.

If swallowed,get medical help or contact a Poison Control Center right away.

Directions

Apply topically as needed to cleanse intended area.

Discard after single use.

Inactive Ingredients

Inactive Ingredients: Water

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ALCOHOL PREP PAD 
isopropyl alcohol swab
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58488-004
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ISOPROPYL ALCOHOL (UNII: ND2M416302) (ISOPROPYL ALCOHOL - UNII:ND2M416302) ISOPROPYL ALCOHOL0.7 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R) 0.3 mL
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:58488-004-011 in 1 PACKAGE; Type 0: Not a Combination Product05/01/2016
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A05/20/2013
Labeler - Tongzhou Ruihong Medical Products Factory (421312726)
Establishment
NameAddressID/FEIBusiness Operations
Tongzhou Ruihong Medical Products Factory 421312726manufacture(58488-004)

Revised: 5/2016
Document Id: 33523ba4-3c79-4a11-e054-00144ff88e88
Set id: 3027b706-450a-44b0-814d-d82b55ed6ce2
Version: 2
Effective Time: 20160520
 
Tongzhou Ruihong Medical Products Factory