SANI-KURE EXTRA STRENGTH HAND SANITIZER- alcohol solution

Nchi: Marekani

Lugha: Kiingereza

Chanzo: NLM (National Library of Medicine)

Viambatanisho vya kazi:

ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)

Inapatikana kutoka:

KOLORCURE CORPORATION

Njia ya uendeshaji:

TOPICAL

Dawa ya aina:

OTC DRUG

Matibabu dalili:

Antimicrobial in or around the eys.

Idhini hali ya:

OTC monograph not final

Tabia za bidhaa

SANI-KURE EXTRA STRENGTH HAND SANITIZER- ALCOHOL SOLUTION
KOLORCURE CORPORATION
_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)
Alcohol 70% v/v. Purpose: Antimicrobial
USE
USE:
Antimicrobial
WARNINGS
Flammable. Keep away from heat or flame. Harmful if swallowed. For
external use only.
DO NOT USE
in or around the eys.
In case of contact immediately flush eyes with water.
If swallowed, contact physician.
Keep out of reach of children.
DIRECTIONS
Place enough product in your palm to cover hands. Rub hands together
until dry.
Children under 6 years of age should be supervised when using
Sani-Kure.
OTHER INFORMATION
Do not store above 110°F.
INACTIVE INGREDIENTS
Pure Aloe Vera, vegetable glycerin, isopropyl alcohol, hydrogen
peroxide, distilled water.
WARNINGS
Keep out of reach of children.
PACKAGE LABEL - PRINCIPAL DISPLAY PANEL
2 FL OZ (59 mL)
4 FL OZ (118 mL)
8 oz (236 mL)
SANI-KURE EXTRA STRENGTH HAND SANITIZER
alcohol solution
PRODUCT INFORMATION
PRODUCT TYPE
HUMAN OTC DRUG
ITEM CODE (SOURCE)
NDC:78923-001
ROUTE OF ADMINISTRATION
TOPICAL
ACTIVE INGREDIENT/ACTIVE MOIETY
INGREDIENT NAME
BASIS OF STRENGTH
STRENGTH
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)
ALCOHOL
74 mL in 100 mL
INACTIVE INGREDIENTS
INGREDIENT NAME
STRENGTH
ALOE VERA WHOLE (UNII: KIZ4X2EHYX)
15 mL in 100 mL
KOLORCURE CORPORATION
GLYCERIN (UNII: PDC6A3C0OX)
2.1 mL in 100 mL
HYDROGEN PEROXIDE (UNII: BBX060AN9V)
1.8 mL in 100 mL
WATER (UNII: 059QF0KO0R)
7.1 mL in 100 mL
PACKAGING
# ITEM CODE
PACKAGE DESCRIPTION
MARKETING START
DATE
MARKETING END
DATE
1
NDC:78923-
001-04
118 mL in 1 BOTTLE, SPRAY; Type 0: Not a
Combination Product
03/30/2020
2
NDC:78923-
001-08
236 mL in 1 BOTTLE, SPRAY; Type 0: Not a
Combination Product
03/30/2020
MARKETING INFORMATION
MARKETING
CATEGORY
APPLICATION NUMBER OR MONOGRAPH
CITATION
MARKETING START
DATE
MARKETING END
DA