SEAL NON ALCOHOL BASED HAND SANITIZER- benzalkonium chloride gel 
ATLANTIC CARE CHEMICALS PRIVATE 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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SEAL Non Alcohol based Hand sanitizer gel

Drug Facts

Purpose: Antiseptic

ACTIVE INGREDIENTS

Component

Benzalkonium chloride - 0.5 %

INACTIVE INGREDIENTS

Boro Glycerine, Carbomer, Triethanolamine, Methyl salicylate, Water, Citric acid, Vitamine E.

Use: Hand Sanitizer to help reduce microbes that potentially can cause disease. For use when soap and water are not available

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 occurs, please consult a doctor.

Do not use

• In children less than 2 months of age

• On open skin wounds.

Warning

• For external use only

• Keep out of Reach of Children

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.

Other information

• Store between 15-30°C (59-86F)

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

Manufactured by:
Atlantic Care Chemicals. Pvt. Ltd
Industrial Development Plot,
Alappuzha, Kerala, India.

9001:2015

ISO CERTIFIED COMPANY

PASSION FOR INNOVATION

care@atlanticchemicals.com
www.atlanticchemicals.com

MADE IN INDIA

Packaging

Seal2

SEAL NON ALCOHOL BASED HAND SANITIZER 
benzalkonium chloride gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:77249-104
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE5 g  in 1 L
Inactive Ingredients
Ingredient NameStrength
BOROGLYCERIN (UNII: U3LMU4AN21)  
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)  
TROLAMINE (UNII: 9O3K93S3TK)  
METHYL SALICYLATE (UNII: LAV5U5022Y)  
WATER (UNII: 059QF0KO0R)  
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
.ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:77249-104-455 L in 1 CAN; Type 0: Not a Combination Product05/15/2020
2NDC:77249-104-010.1 L in 1 BOTTLE; Type 0: Not a Combination Product05/15/2020
3NDC:77249-104-020.2 L in 1 BOTTLE; Type 0: Not a Combination Product05/15/2020
4NDC:77249-104-050.5 L in 1 BOTTLE; Type 0: Not a Combination Product05/15/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A05/15/2020
Labeler - ATLANTIC CARE CHEMICALS PRIVATE LIMITED (861499902)
Establishment
NameAddressID/FEIBusiness Operations
ATLANTIC CARE CHEMICALS PRIVATE LIMITED861499902manufacture(77249-104)

Revised: 5/2020
Document Id: 9d2981aa-caf6-4e02-810b-3627091be0a1
Set id: 3981758e-3c8d-427d-94c3-9428c59139d5
Version: 1
Effective Time: 20200521
 
ATLANTIC CARE CHEMICALS PRIVATE LIMITED