AMORAY 99% ISOPROPYL RUBBING ALCOHOL- isopropyl alcohol liquid 
MY IMPORT USA INC

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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AMORAY 99% ISOPROPYL RUBBING ALCOHOL

Active ingredient (by volume)

Isopropyl alcohol (99% concentrate)

Purpose

topical antimicrobial

Uses

Warnings

For external use only

Ask a doctor before use if you have deep puncture wounds or serious burns

When using this product

Stop use and ask a doctor if condition persists or gets worse

Keep out of reach of children.

In case of an accidental ingestion, contact a Poison Control Center immediately

Directions

Other information

Inactive ingredient

Water

PRINCIPAL DISPLAY PANEL

alcohol-99

AMORAY 99% ISOPROPYL RUBBING ALCOHOL 
isopropyl alcohol liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:51628-1017
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ISOPROPYL ALCOHOL (UNII: ND2M416302) (ISOPROPYL ALCOHOL - UNII:ND2M416302) ISOPROPYL ALCOHOL99 mL  in 100 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:51628-1017-1355 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product08/11/2020
2NDC:51628-1017-2473 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product08/11/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A08/11/2020
Labeler - MY IMPORT USA INC (195767988)
Registrant - Jell Pharmaceuticals Pvt. Ltd. (726025211)
Establishment
NameAddressID/FEIBusiness Operations
Jell Pharmaceuticals Pvt. Ltd.726025211manufacture(51628-1017)

Revised: 8/2020
Document Id: ac93f7ba-8584-0747-e053-2a95a90a752b
Set id: 649e9887-6657-4b51-8874-9914e96e2d36
Version: 1
Effective Time: 20200811
 
MY IMPORT USA INC