ALL CLEAR 500ML HAND SANITIZER 70%

ALL CLEAR by

Drug Labeling and Warnings

ALL CLEAR by is a Otc medication manufactured, distributed, or labeled by BOTANICALS INTERNACIONAL S.A. DE C.V., GoodFibers LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ALL CLEAR- hand sanitizer- alcohol gel gel 
BOTANICALS INTERNACIONAL S.A. DE C.V.

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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ALL CLEAR 500ML HAND SANITIZER 70%

Active Ingredient

Ethyl alcohol 70%

Purpose

Antimicrobial

Warnings

Warnings

• For External use only Flammable
• Keep away from fire or flame

Stop Use

Stop use and ask doctor

• If irritation and redness persist for more then 72 hours.

Keep out of reach

Keep out of reach of children

In case of accidental ingestion, seek medicalattention or contact a poison control center immediately

Uses

• Hand sanitizer to decrease bacteria on the skin
• Recommended for repeated use

Directions

DIRECTIONS

• Place enough product on your palm to thoroughly spread on both hands and rub into the skin until dry.
• Children under six years of age should be supervised when using this product.

Storage

Other Information

• Store at 1°C - 30°C (34 °F - 86 °F)

Inactive ingredients

Inactive Ingredients

• Carbomer, Glycerin, Triethanolamine, Water

ADMINISTRATION

• Place enough product on your palm to thoroughly spread on both hands and rub into the skin until dry.
• Children under six years of age should be supervised when using this product.

PDP

500ML

NDC: 51384-004-01

NDC SOURCE: 77070-700-80

ALL CLEAR 
hand sanitizer- alcohol gel gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 51384-004
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
ACRYLIC ACID (UNII: J94PBK7X8S)	0.5 mL  in 100 mL
WATER (UNII: 059QF0KO0R)	28 mL  in 100 mL
TROLAMINE (UNII: 9O3K93S3TK)	0.5 mL  in 100 mL
GLYCERIN (UNII: PDC6A3C0OX)	1 mL  in 100 mL

Product Characteristics
Color	white (colorless)	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 51384-004-01	500 mL in 1 BOTTLE; Type 0: Not a Combination Product	07/07/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333E	07/07/2020	12/01/2020

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

Registrant - GoodFibers LLC (105870470)

Establishment
Name	Address	ID/FEI	Business Operations
BOTANICALS INTERNACIONAL S.A. DE C.V.		823968961	manufacture(51384-004)

Revised: 5/2021

Document Id: c2db140f-a309-3fdd-e053-2a95a90adac5

34390-5

Set id: a952ea0e-6429-cee5-e053-2a95a90ac386

Version: 2

Effective Time: 20210521