RUBBING ALCOHOL- isopropyl alcohol liquid 
Nobum Labs, S.A.P.I. de C.V.

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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Rubbing Alcohol (IPA )

Active Ingredient(s)

Isopropyl Alcohol 70% v/v. Purpose: First Aid Antiseptic

Purpose

First Aid Antiseptic

Use

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

Warnings

For external use only.

Keep away from heat or flame. If taken internally serious gastric disturbances will result.

Ask a doctor before use if you have deep or puncture wounds, animal bites or serious burns.

* do not get into eyes.

* do not apply over large areas of the body.
*do not use longer than one week unless directed by a doctor.

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

In case of ingestion, get medical help or call Poison Control Center immediately.

Directions

* clean affected area

*apply small amount of this product on the area 1-3 times daily

* If bandaged, lets dry first may be covered with a sterile bandage

Other information

store at room temperature does not contain, nor is intended as a sustitute for grain or ethyl alcohol.

Inactive ingredients

purified water.

Package Label - Principal Display Panel
500 ml NDC: 81213-001-01

500 ml NDC: 81213-001-01

Rubbing_Alcohol

946 mL NDC: 81213-001-02

946 mL NDC: 81213-001-02

Rubbing_Alcohol

RUBBING ALCOHOL 
isopropyl alcohol liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:81213-001
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ISOPROPYL ALCOHOL (UNII: ND2M416302) (ISOPROPYL ALCOHOL - UNII:ND2M416302) ISOPROPYL ALCOHOL70 mL  in 100 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R) 30 mL  in 100 mL
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:81213-001-01500 mL in 1 BOTTLE; Type 0: Not a Combination Product01/24/2022
2NDC:81213-001-02946 mL in 1 BOTTLE; Type 0: Not a Combination Product01/24/2022
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A01/24/2022
Labeler - Nobum Labs, S.A.P.I. de C.V. (951588419)
Registrant - Nobum Labs, S.A.P.I. de C.V. (951588419)
Establishment
NameAddressID/FEIBusiness Operations
Nobum Labs, S.A.P.I. de C.V.951588419manufacture(81213-001)

Revised: 1/2022
Document Id: d69523ea-ef7f-f06f-e053-2a95a90ac931
Set id: b555ef03-ceb5-77d9-e053-2995a90a13d5
Version: 2
Effective Time: 20220127
 
Nobum Labs, S.A.P.I. de C.V.