HYGIENE HERO- super mist multi-purpose organic hand sanitizer liquid 
Linea Bly SRL

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)

Alcohol 80% v/v. Purpose: Antiseptic

Purpose

Antiseptic, Hand Sanitizer

Use

to help reduce bacteria on the skin

Warnings

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

Do not use

near eyes. In case of contact, rinse eyes thoroughly with water.

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.

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.

Directions

Spray on palm, rub together until dry. Supervise children under 6.

Other information

Do not store above 104°F (40°C)。Avoid placing under direct sun.

Inactive ingredients

Water (Aqua), Bitter Orange (Citrus aurantium amara) peel oil*, Tea tree (Melaleuca Alternifolia) leaf oil*, May Chang (Litsea cubeba) fruit oil*, Limonene, Citral.

Package Label - Principal Display Panel

100 mL NDC:74540-246-01

HYGIENE HERO 
super mist multi-purpose organic hand sanitizer liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:74540-246
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL75 mL  in 100 mL
Inactive Ingredients
Ingredient NameStrength
CITRAL (UNII: T7EU0O9VPP)  
TEA TREE OIL (UNII: VIF565UC2G)  
LIMONENE, (+)- (UNII: GFD7C86Q1W)  
LITSEA OIL (UNII: 2XIW34BN6O)  
BITTER ORANGE OIL (UNII: 9TLV70SV6I)  
LEMON OIL, TERPENELESS (UNII: X69W83NI7V)  
WATER (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:74540-246-01100 mL in 1 BOTTLE; Type 0: Not a Combination Product03/30/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A03/30/2020
Labeler - Linea Bly SRL (441014352)
Establishment
NameAddressID/FEIBusiness Operations
Linea Bly SRL441014352manufacture(74540-246)

Revised: 4/2020
Document Id: a3f17fd3-b3c1-97fb-e053-2995a90a580e
Set id: a3f1ab03-6945-9827-e053-2995a90a625f
Version: 1
Effective Time: 20200423
 
Linea Bly SRL