ASSURED - isopropyl alcohol patch 
SHANGHAI YINJING MEDICAL SUPPLIES 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.

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Drug Facts

Inactive Ingredients:  Water

Active Ingredient

Isopropyl Alcohol 70% v/v

Purpose

Antiseptic

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

Uses

First aid to help prevent the risk of infection in minor cuts, scrapes and burns

For preparation of the skin prior to injection

Warnings

For external use only

Flammable. Keep away from fire or flame

Directions

Apply to skin as needed

Discard after single use

Do not use

-in contact with eyes or with mucous membranes

-more than 7 days unless directed by a doctor

-over large areas of the body

-on deep or puncture wounds, animal bites or serious burns

Stop use and ask a doctor if

-excessive irritation and redness develop

-condition gets worse or persists for more than 7 days

copy of label

ASSURED 
isopropyl alcohol patch
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:55310-001
Route of Administration TOPICAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ISOPROPYL ALCOHOL (UNII: ND2M416302) (ISOPROPYL ALCOHOL - UNII:ND2M416302) ISOPROPYL ALCOHOL .70 mL  in 1 mL
Inactive Ingredients
Ingredient Name Strength
WATER (UNII: 059QF0KO0R)  
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:55310-001-01 300 mL in 1 POUCH
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph not final part333A 01/04/2013
Labeler - SHANGHAI YINJING MEDICAL SUPPLIES CO., LTD. (530501535)
Establishment
Name Address ID/FEI Business Operations
SHANGHAI YINJING MEDICAL SUPPLIES CO., LTD. 530501535 manufacture(55310-001)

Revised: 1/2013
Document Id: 92cccc28-94a8-4b0d-9d46-94b1b7374e7d
Set id: e909eb0b-bc55-41e5-82e2-0edcfd160e6c
Version: 3
Effective Time: 20130109
 
SHANGHAI YINJING MEDICAL SUPPLIES CO., LTD.