B4 HAND SANITIZER 500 SINGLE-USE PACKS- alcohol gel
FasPac Packaging, LP

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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B4 Hand Sanitizer

500 Single-use gel packs

DRUG FACTS

Active Ingredient

Ethyl Alcohol 62% w/w

PURPOSE

Antimicrobial

Uses

to sanitize hands without water

kills 99% of most common bacteria

Warnings

FLAMMABLE. For external use only

When using this product

Keep away from fire or flame.

Do not use in the eyes.

Discontinue use if irritation or redness develop.

Keep out of reach of children

If swallowed get medical help or contact a Poison Control Center immediately.

Directions

Tear open packet and apply entire amount of gel to unsoild hands.

Rub in thoroughly until hands are dry.

Do not wipe or use water rinse.

Other information

store at room temperature.

Inactive Ingredients

Water, Aloe Very Gel, Carbomer, Diisopropylamine, Glycerin, Isopropyl Myristate, Fragrance, Phenoxyethanol, Tocopheryl Acetate, D&C Yellow #10, FD&C Yellow #5, Blue #1

Distributed by

Midway Advanced Products

800 Town & Country Blvd., Suite 200

Houston, TX 77024

888.238.9284

Product labeling

labels

B4 HAND SANITIZER 500 SINGLE-USE PACKS
alcohol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:52701-100
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	62 mL in 100 mL

Ingredient Name	Strength
Inactive Ingredients
WATER (UNII: 059QF0KO0R)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
DIISOPROPYLAMINE (UNII: BR9JLI40NO)
GLYCERIN (UNII: PDC6A3C0OX)
ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
TOCOPHEROL (UNII: R0ZB2556P8)
D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:52701-100-10	500 in 1 BOX	09/15/2015	03/01/2017
1		1.2 mL in 1 PACKAGE; Type 0: Not a Combination Product
2	NDC:52701-100-14	100 in 1 BOX	09/15/2015	10/06/2015
2		1.2 mL in 1 PACKAGE; Type 0: Not a Combination Product
3	NDC:52701-100-13	50 in 1 BOX	09/15/2015	03/01/2017
3		1.2 mL in 1 PACKAGE; Type 0: Not a Combination Product
4	NDC:52701-100-12	25 in 1 BOX	09/15/2015	03/01/2017
4		1.2 mL in 1 PACKAGE; Type 0: Not a Combination Product
5	NDC:52701-100-18	24 in 1 BOX	10/06/2015	03/01/2017
5		6 mL in 1 BLISTER PACK; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part333E	09/15/2015	03/01/2017

Labeler - FasPac Packaging, LP (849907266)

Revised: 9/2017

Document Id: 5a04842a-c10e-83ac-e053-2991aa0a0a42

Set id: 780a0f52-585f-4af6-80a0-e4db67d3627b

Version: 6

Effective Time: 20170925

FasPac Packaging, LP

B4 Hand Sanitizer 500 Single-use gel packs