RUBICON Alcohol Wipes 100-200 PCS

NIMBUS9 by

Drug Labeling and Warnings

NIMBUS9 by is a Otc medication manufactured, distributed, or labeled by RUBICON VENTURE LLC, ENTAID INTERNATIONAL. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

NIMBUS9- sanitizing wipes swab 
RUBICON VENTURE 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.

----------

RUBICON Alcohol Wipes 100-200 PCS

Active Ingredient(s)

Alcohol 75% v/v

Purpose

Antiseptic

Use

For hand cleaning to help reduce bacteria on the skin. For use when soap and water are not available.

Warnings

For external use only. Flammable. Keep away from heat or flame.

Do not use

in or near the eyes.

in children less than 2 months of age
on open skin wounds or burns

When using this product keep out of eyes, ears, and mouth. In case of contact with eyes, rinse eyes thoroughly with water.
Stop use and ask a doctor if irritation or rash occurs. These may be signs of a serious condition.
Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Discontinue use and ask a doctor if irritation or redness occurs. If condition persists for more than 72 hours consult a physician.

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

Directions

• Wipe hands thoroughly with product, and discard after a single use.
• Children under 6 years of age should be supervised when using this product.

Other information

• Store between 15-30 C (59-86F)
• Avoid freezing and excessive heat above 40C (104F)

Inactive ingredients

water.

Package Label - Principal Display Panel

100 PCS NDC: 81405-111-11

NIMBUS9 
sanitizing wipes swab

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 81405-111
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	75 mL  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 81405-111-11	100 in 1 CANISTER	01/23/2021
1		100 mL in 1 NOT APPLICABLE; Type 0: Not a Combination Product
2	NDC: 81405-111-12	200 in 1 CANISTER	01/23/2021
2		200 mL in 1 NOT APPLICABLE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	01/23/2021

Labeler - RUBICON VENTURE LLC (079868466)

Establishment
Name	Address	ID/FEI	Business Operations
ENTAID INTERNATIONAL		673067577	manufacture(81405-111)

Revised: 1/2021

Document Id: b99494c7-3c88-0b65-e053-2a95a90a6f4f

34390-5

Set id: b99494c7-3c87-0b65-e053-2a95a90a6f4f

Version: 1

Effective Time: 20210123