B4 HAND SANITIZER- ethyl alcohol gel
Midway Advanced Products, 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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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 unsoiled 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 Vera Gel, Carbomer, Diisopropylamine, Glycerin, Isopropyl Myristate, Fragrance, Phenoxyethanol, Tocopheryl Acetate, D and C Yellow #10, FD and C Yellow #5, FD and C Blue #1

Distributed by

Midway Advanced Products, LLC
1-713-629-5200
800 Town and Country Blvd, Suite 200, Houston, TX 77024

Product Labeling

label

B4 HAND SANITIZER
ethyl alcohol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:52490-100
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	42 mg in 25 mL

Ingredient Name	Strength
Inactive Ingredients
WATER (UNII: 059QF0KO0R)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
CARBOMER HOMOPOLYMER TYPE C (UNII: 4Q93RCW27E)
DIISOPROPYLAMINE (UNII: BR9JLI40NO)
GLYCERIN (UNII: PDC6A3C0OX)
ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
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:52490-100-12	25 in 1 BOX	09/15/2010	12/01/2017
1		1.2 mL in 1 PACKET; Type 0: Not a Combination Product
2	NDC:52490-100-13	50 in 1 BOX	09/15/2010	12/01/2017
2		1.2 mL in 1 PACKET; Type 0: Not a Combination Product
3	NDC:52490-100-14	100 in 1 BOX	09/15/2010	12/01/2017
3		1.2 mL in 1 PACKET; Type 0: Not a Combination Product
4	NDC:52490-100-10	500 in 1 BOX	09/15/2010	12/01/2017
4		1.2 mL in 1 PACKET; Type 0: Not a Combination Product
5	NDC:52490-100-18	24 in 1 BOX	10/06/2015	12/01/2017
5		6 mL in 1 BLISTER PACK; Type 0: Not a Combination Product
6	NDC:52490-100-21	237 mL in 1 BOTTLE; Type 0: Not a Combination Product	10/06/2015	12/01/2017
7	NDC:52490-100-17	800 mL in 1 BOTTLE, DISPENSING; Type 0: Not a Combination Product	10/06/2015	12/01/2017

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part333A	09/15/2010	12/01/2017

Labeler - Midway Advanced Products, LLC (962765009)

Registrant - Carroll Company (007372329)

Revised: 12/2017

Document Id: 5fc4970a-7e44-a9b2-e053-2991aa0a3939

Set id: 1ff88134-4b06-4161-8c16-2572e3f0636d

Version: 8

Effective Time: 20171207

Midway Advanced Products, LLC