PARACHUTE HAND PROTECT GEL- alcohol gel 
DBDBLAB corp.

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.

----------

81135-001_Parachute Hand Protect Gel

Active ingredient

Ethyl alcohol 70%

Purpose

Antimicrobial

Use

To decrease bacteria on the skin

Warnings

Flammable. Keep away from fire or flame. 

For external use only

When using this product do not use in or near the eyes. In case of contact, rinse eyes thoroughly with water

Stop use and ask a doctor if irritation or rash appears and lasts

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

Directions

Inactive Ingredients:

Water, PEG-60 Hydrogenated Castor Oil, Carbomer, Tetrahydroxypropyl Ethylenediamine, Eucalyptus Radiata Leaf Oil, 1,2-Hexanediol, Betaine, Caprylyl Glycol, Glycerin, Juniperus Communis Fruit Oil, Lavandula Angustifolia (Lavender) Oil, Citrus Paradisi (Grapefruit) Peel Oil, Butylene Glycol, Melaleuca Alternifolia (Tea Tree) Leaf Oil, Menthol, Artemisia Annua Extract, Azadirachta Indica Leaf Extract, Camellia Sinensis Leaf Extract, Centella Asiatica Extract, Chamomilla Recutita (Matricaria) Flower Extract, Mentha Rotundifolia Leaf Extract, Eucalyptus Globulus Leaf Extract, Melaleuca Alternifolia (Tea Tree) Leaf Extract

Product Label

PARACHUTE HAND PROTECT GEL 
alcohol gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:81135-001
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL0.7 mL  in 1 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
PEG-60 HYDROGENATED CASTOR OIL (UNII: 02NG325BQG)  
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)  
EDETOL (UNII: Q4R969U9FR)  
EUCALYPTUS OIL (UNII: 2R04ONI662)  
1,2-HEXANEDIOL (UNII: TR046Y3K1G)  
BETAINE (UNII: 3SCV180C9W)  
CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
GLYCERIN (UNII: PDC6A3C0OX)  
JUNIPER BERRY OIL (UNII: SZH16H44UY)  
GRAPEFRUIT OIL (UNII: YR377U58W9)  
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
LAVENDER OIL (UNII: ZBP1YXW0H8)  
TEA TREE OIL (UNII: VIF565UC2G)  
MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A)  
AZADIRACHTA INDICA LEAF (UNII: HKY915780T)  
GREEN TEA LEAF (UNII: W2ZU1RY8B0)  
CENTELLA ASIATICA WHOLE (UNII: 7M867G6T1U)  
CHAMOMILE (UNII: FGL3685T2X)  
MENTHA SUAVEOLENS LEAF (UNII: 1341ZC68MK)  
EUCALYPTUS GLOBULUS LEAF (UNII: S546YLW6E6)  
MELALEUCA ALTERNIFOLIA LEAF (UNII: G43C57162K)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:81135-001-021 in 1 CARTON01/18/2021
1NDC:81135-001-01400 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333E01/18/2021
Labeler - DBDBLAB corp. (695584806)
Establishment
NameAddressID/FEIBusiness Operations
Ecoment688485136manufacture(81135-001)

Revised: 1/2021
Document Id: b93508cf-8fa1-2f02-e053-2a95a90aa0ac
Set id: 402aeb78-a192-419e-976b-f861a624275b
Version: 1
Effective Time: 20210118
 
DBDBLAB corp.