ALCOHOL BASED HAND SANITIZER TOTAL PURE- hand sanitizer gel

ALCOHOL BASED HAND SANITIZER TOTAL PURE by

Drug Labeling and Warnings

ALCOHOL BASED HAND SANITIZER TOTAL PURE by is a Otc medication manufactured, distributed, or labeled by BOTANICALS INTERNACIONAL S.A. DE C.V.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

1000ML ACTIVE INGREDIENT

1000 ML NDC: 51384-003-01

1000ML KEEP OUT OF REACH SECTION

1000ML NDC: 51384-003-01

1000ML PURPOSE

1000ML NDC: 51384-003-01

1000ML WARNINGS AND PRECAUTION

1000ML NDC: 51384-003-01

1000ML DOSAGE AND ADMIN.

1000ML NDC: 51384-003-01

1000ML INDICATIONS AND USAGE

1000ML NDC: 51384-003-01

1000ML WARNING SECTION

1000ML NDC: 51384-003-01

500ml Active ingedient.

500ML NDC: 51384-003-02

500ML PURPOSE

500ML NDC: 51384-003-02

500ML WARININGS AND PRECAUTIONS

500ML NDC: 51384-003-002

500ML DOSAGE AND ADMINISTRATION

500ML NDC: 51384-003-02

500ML INDICATIONS AND USAGE SECTION

500ML NDC: 51384-003-02

500ML WARNINGS

500ML NDC: 51384-003-02

1000ML INACTIVE INGREDIENTS

1000ML NDC: 51384-003-01

500ML INACTIVE INGREDIENTS

500ML NDC: 51384-003-02

1000ML FRONT DISPLAY

1000ML NDC: 51384-003-01

500ML FRONT LABEL DISPLAY

500ML NDC: 51384-003-002

INGREDIENTS AND APPEARANCE

ALCOHOL BASED HAND SANITIZER TOTAL PURE 
hand sanitizer gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 51384-003
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	70 mL  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
CARBOMER 940 (UNII: 4Q93RCW27E)	0.25 mL  in 100 mL
TROLAMINE (UNII: 9O3K93S3TK)	0.25 mL  in 100 mL
WATER (UNII: 059QF0KO0R)	29.3 mL  in 100 mL
GLYCERIN (UNII: PDC6A3C0OX)	0.2 mL  in 100 mL

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 51384-003-01	1000 mL in 1 BOTTLE; Type 0: Not a Combination Product	05/29/2020
2	NDC: 51384-003-02	500 mL in 1 BOTTLE; Type 0: Not a Combination Product	05/29/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	05/29/2020

Labeler - BOTANICALS INTERNACIONAL S.A. DE C.V. (823968961)

Registrant - BOTANICALS INTERNACIONAL S.A. DE C.V. (823968961)

Establishment
Name	Address	ID/FEI	Business Operations
BOTANICALS INTERNACIONAL S.A. DE C.V.		823968961	manufacture(51384-003)