HAND SANITISER- isopropyl alcohol spray 
WESTBARNCO 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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Active Ingredient(s)

Isopropyl Alcohol 67% w/w

Drug Facts

Purpose

Antiseptic

Use(s)

Hand sanitiser spray to help reduce bacteria that potentially can cause disease. 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 children less than 2 months of age

• on open skin wounds

When using this product

keep out of eyes, ears, and mouth. In case of contact with eyes, rinse eyes thoroughly with water.

Stop use

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.

Directions

• Place enough product on hands to cover all surfaces. Rub hands together until dry.

• Supervise children under 6 years of age when using this product to avoid swallowing.

Dosage

wet hands thoroughly with product and allow to dry without wiping

Other Information

• Store between 15-30C (59-86F)

• Avoid freezing and excessive heat above 40C (104F)

Inactive ingredients

Mentha piperita leaf water, Glycerin, Mentha piperita oil, Eucalyptus globulus leaf oil, Phenoxyethanol, Ethylhexylglycerin, Limonene, CI 42090, CI 16035.

50ml. 76916-167-15

50ml Label

Directions

200ml. 76916-167-12

200ml Label.Directions.

HAND SANITISER 
isopropyl alcohol spray
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:76916-167
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ISOPROPYL ALCOHOL (UNII: ND2M416302) (ISOPROPYL ALCOHOL - UNII:ND2M416302) ISOPROPYL ALCOHOL0.67 mL  in 50 mL
Inactive Ingredients
Ingredient NameStrength
FD&C BLUE NO. 1 (UNII: H3R47K3TBD) 0.000028 mL  in 50 mL
PEPPERMINT OIL (UNII: AV092KU4JH) 0.0008 mL  in 50 mL
PHENOXYETHANOL (UNII: HIE492ZZ3T) 0.0000108 mL  in 50 mL
WATER (UNII: 059QF0KO0R) 0.001135 mL  in 50 mL
FD&C RED NO. 40 (UNII: WZB9127XOA) 0.000025 mL  in 50 mL
GLYCERIN (UNII: PDC6A3C0OX) 0.1 mL  in 50 mL
EUCALYPTUS OIL (UNII: 2R04ONI662) 0.0008 mL  in 50 mL
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P) 0.0000012 mL  in 50 mL
MENTHA PIPERITA LEAF (UNII: A389O33LX6) 0.2272 mL  in 50 mL
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:76916-167-1550 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product05/10/2020
2NDC:76916-167-12200 mL in 1 BOTTLE; Type 0: Not a Combination Product05/10/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A05/10/2020
Labeler - WESTBARNCO LTD (222350573)

Revised: 12/2020
Document Id: b696ab62-bc1e-2649-e053-2a95a90a5e59
Set id: a442a4cd-95d2-038a-e053-2a95a90aa5e8
Version: 2
Effective Time: 20201216
 
WESTBARNCO LTD