Alcohol Sentinel Boxset by Sunrise Healthcare Technology Limited Sunrise 004-01

Alcohol Sentinel Boxset by

Drug Labeling and Warnings

Alcohol Sentinel Boxset by is a Otc medication manufactured, distributed, or labeled by Sunrise Healthcare Technology Limited. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ALCOHOL SENTINEL BOXSET- alcohol sentinel liquid 
Sunrise Healthcare Technology Limited

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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Sunrise 004-01

Active Ingredient(s)

Alcohol 75% . Purpose: Antimicrobial

Purpose

Antimicrobial

Use

Sanitizes hand, body, hair, and household to reduce bacteria that potentially can cause disease.

Recommended for repeated daily use.

Warnings

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

Do not use

Sanitizes hand, body, hair, and household to reduce bacteria that potentially can cause disease.

Recommended for repeated daily use.

In case of contact, rinse eyes thoroughly with water.

Stop use and ask a doctor if irritation and redness develop and persist for more than 72 hours.

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 and redness develop and persist for more than 72 hours.

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

Directions

Remove the cap and press the top of the head to spray directly on Hand. Body Hair, and household use, then allow approximately 30 seconds for evaporation

Other information

Store under 40˚C (104˚F)

Inactive ingredients

Parfum, Glycerin, Octoxyglerin, Benzalkonium Chloride, Water

Package Label - Principal Display Panel

Front and Back Labels3 Spray Bottles each 10 mL NDC: 80886-004-01

ALCOHOL SENTINEL BOXSET 
alcohol sentinel liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 80886-004
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
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
GLYCERIN (UNII: PDC6A3C0OX)  
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7)  
WATER (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 80886-004-013 in 1 BOX10/26/2020
110 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A10/26/202012/15/2021
Labeler - Sunrise Healthcare Technology Limited (687125438)
Establishment
NameAddressID/FEIBusiness Operations
Sunrise Healthcare Technology Limited687125438label(80886-004)

Revised: 2/2022
Document Id: d79d19e3-df53-73ad-e053-2995a90abc14
Set id: b29d0ed6-9a74-31c8-e053-2a95a90aa2af
Version: 3
Effective Time: 20220209