ANTIBACTERIAL HAND SANITIZER- alcohol liquid 
Ankit LLC

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

Alcohol 75% v/v.

Purpose

Antiseptic

Uses

Eliminate bacteria and viral matter on the skin.

Warnings

Do not use

When using:

Avoid contact with face. eyes. and broken skin. In case of eye contact, flush with clean water and seek medical assistance.

Stop use and contact a doctor if:
Irritation or redness occurs.

Keep out of reach of children. In case of ingestion. seek medical help or contact a Poison Control Center immediately.

Directions

Other information

Inactive ingredients

Water, Aloe, Carbomer, Triethanolamine.

Package Label - Principal Display Panel

Label

ANTIBACTERIAL HAND SANITIZER 
alcohol liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:78887-001
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
WATER (UNII: 059QF0KO0R)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)  
TROLAMINE (UNII: 9O3K93S3TK)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:78887-001-0129 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product06/13/2020
2NDC:78887-001-0259 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product06/13/2020
3NDC:78887-001-03100 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product06/13/2020
4NDC:78887-001-04118 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product06/13/2020
5NDC:78887-001-05237 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product06/13/2020
6NDC:78887-001-06250 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product06/13/2020
7NDC:78887-001-07473 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product06/13/2020
8NDC:78887-001-08500 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product06/13/2020
9NDC:78887-001-09887 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product06/13/2020
10NDC:78887-001-10946 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product06/13/2020
11NDC:78887-001-111000 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product06/13/2020
12NDC:78887-001-122000 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product06/13/2020
13NDC:78887-001-133000 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product06/13/2020
14NDC:78887-001-143800 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product06/13/2020
15NDC:78887-001-154000 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product06/13/2020
16NDC:78887-001-165000 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product06/13/2020
17NDC:78887-001-177600 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product06/13/2020
18NDC:78887-001-1810000 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product06/13/2020
19NDC:78887-001-1911400 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product06/13/2020
20NDC:78887-001-2018900 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product06/13/2020
21NDC:78887-001-2120000 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product06/13/2020
22NDC:78887-001-2237900 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product06/13/2020
23NDC:78887-001-2350000 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product06/13/2020
24NDC:78887-001-24100000 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product06/13/2020
25NDC:78887-001-25150000 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product06/13/2020
26NDC:78887-001-26200000 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product06/13/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A06/13/2020
Labeler - Ankit LLC (805718140)

Revised: 6/2020
Document Id: 5057eaa2-8fca-4644-b35b-4831aa48d588
Set id: 39f3126d-475c-41a3-84ae-110201249df5
Version: 1
Effective Time: 20200614
 
Ankit LLC