HYDRO ALCOHOL GEL- alcohol gel
BRENNTAG MID-SOUTH, 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.
----------
Active Ingredient(s)

Purpose
Antiseptic

Use(s)

WARNING

KEEP OUT OF REACH OF CHILDREN

Inactive ingredients

STORAGE

DIRECTION
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.
Product Name

HYDRO ALCOHOL GEL
alcohol gel |
Product Information |
Product Type | HUMAN OTC DRUG | Item Code (Source) | NDC: 65353-9664 |
Route of Administration | TOPICAL |
|
Active Ingredient/Active Moiety |
Ingredient Name | Basis of Strength | Strength |
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) | ALCOHOL | 80 L in 100 L |
|
Inactive Ingredients |
Ingredient Name | Strength |
WATER (UNII: 059QF0KO0R) | |
HYDROXYPROPYL CELLULOSE, UNSPECIFIED (UNII: 9XZ8H6N6OH) | 1.1 L in 100 L |
GLYCERIN (UNII: PDC6A3C0OX) | 2.5 L in 100 L |
|
|
Packaging |
# | Item Code | Package Description | Marketing Start Date | Marketing End Date |
1 | NDC: 65353-9664-1 | 26000 L in 1 TANK; Type 0: Not a Combination Product | 05/05/2020 | |
2 | NDC: 65353-9664-3 | 208 L in 1 DRUM; Type 0: Not a Combination Product | 05/05/2020 | |
3 | NDC: 65353-9664-2 | 1040 L in 1 TANK; Type 0: Not a Combination Product | 05/05/2020 | |
|
|
Marketing Information |
Marketing Category | Application Number or Monograph Citation | Marketing Start Date | Marketing End Date |
OTC monograph not final | part333A | 05/05/2020 | 12/31/2023 |
|
Labeler - BRENNTAG MID-SOUTH, INC.
(122625064)
|
Registrant - BRENNTAG MID-SOUTH, INC. (122625064) |
Establishment |
Name | Address | ID/FEI | Business Operations |
BRENNTAG MID-SOUTH, INC. | | 122625064 | manufacture(65353-9664) , label(65353-9664) |