HAND SANITIZER- benzalkonium chloride gel

DGH Pharma, Inc.

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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Hand Sanitizer

Active Ingredient(s )
Benzalkonium Chloride 0.10% w/w. Purpose: Antiseptic

Purpos e
Antiseptic, Hand Sanitizer

Us e
To eliminate viruses and bacteria on the skin

Warnings
For external use only.
When using this product keep out of eyes. In case of contact, flush eyes with water.

Stop use and ask a doctor if irritation or redness develops

Keep out of reach of children. If swallowed, get medical assistance or contact a Poison Control Center
immediately.
Stop use and ask a doctor if irritation or redness develops.
Keep out of reach of children. If swallowed, get medical assistance or contact a Poison Control Center
immediately.

Directions
Rub thoroughly over all surfaces of both hands.
Rub hands toghether briskly unitl dry.

Inactive ingredients
Aloe Barbadensis Leaf Juice, Citrus Sinensis (Orange) Fruit Oil, Cocamidopropyl PG-Dimonium
Chloride Phosphate, Glycerin, Hydroxyethylcellulose, PEG-8, PEG-90, Potassium Sorbate,
Polysorbate 20, Purified Water, Quercus Borealis Bark Extract

Package Label - Principal Dis play Panel

Impact Divers ity Solutions Label

HAND SANITIZER
benzalkonium chloride gel

Product Information
Prod uct T yp e HUMAN O TC DRUG Ite m Cod e (S ource ) NDC:77238 -221

Route of Ad minis tration TO PICAL

Active Ing redient/Active Moiety

 Ing redient Name Basis o f Streng th Streng th
BENZALKO NIUM CHLO RIDE (UNII: F5UM2KM3W7) (BENZALKO NIUM - BENZALKO NIUM 0 .1 g
UNII:7N6 JUD5X6 Y) CHLO RIDE in 10 0 mL

Inactive Ing redients

Ing redient Name Streng th
PO LYETHYLENE GLYCO L 4 0 0 0 (UNII: 4R4HFI6 D9 5) 2.2 g in 10 0 mL
PO LYETHYLENE GLYCO L 4 0 0 (UNII: B6 9 78 9 4SGQ ) 1.8 g in 10 0 mL
WATER (UNII: 0 59 Q F0 KO 0 R)
Q UERCUS RUBRA BARK (UNII: X26 K8 56 6 JX) 1 g in 10 0 mL
PO LYSO RBATE 2 0 (UNII: 7T1F30 V5YH) 0 .2 g in 10 0 mL
CO CAMIDO PRO PYL PG-DIMO NIUM CHLO RIDE PHO SPHATE (UNII: H2KVQ 74JM4) 1 g in 10 0 mL
ALO E VERA LEAF (UNII: ZY8 1Z8 3H0 X) 1 g in 10 0 mL
HYDRO XYETHYL CELLULO SE, UNSPECIFIED (UNII: T4V6 TWG28 D) 0 .7 g in 10 0 mL
O RANGE O IL (UNII: AKN3KSD11B) 0 .1 g in 10 0 mL
PO TASSIUM SO RBATE (UNII: 1VPU26 JZZ4) 0 .0 5 g in 10 0 mL

Packag ing
# Item Co de Packag e Descriptio n Marketing Start Date Marketing End Date
1 NDC:77238 -221-14 118 mL in 1 BO TTLE; Type 0 : No t a Co mbina tio n Pro duc t 0 6 /22/20 20
2 NDC:77238 -221-24 118 mL in 1 BO TTLE; Type 0 : No t a Co mbina tio n Pro duc t 10 /0 5/20 20

Marketing Information
Marke ting Cate gory Ap p lication Numb e r or Monograp h Citation Marke ting S tart Date Marke ting End Date
O TC mo no gra ph no t fina l pa rt333A 0 6 /22/20 20

Labeler - DGH Pharma, Inc. (128884560)

Registrant - DGH Pharma, Inc. (128884560)

Establishment
Name Ad d re s s ID/FEI Bus ine s s Op e rations
DGH Pha rma , Inc . 128 8 8 456 0 ma nufa c ture (77238 -221)

Revised: 10/2020 DGH Pharma, Inc.