Hand Sanitizer PLD template II

Vindicator - E by

Drug Labeling and Warnings

Vindicator - E by is a Otc medication manufactured, distributed, or labeled by Kimball Midwest, QuestSpecialty Corporation. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

VINDICATOR - E- vindicator - e liquid 
Kimball Midwest

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 PLD template II

Active Ingredient

Ethyl Alcohol 60%..........Antiseptic

purpose

Antiseptic

Uses

• Handwash to help decrease bacterial on the skin.
• Recommended for repeated use.

Warnings

• Flammable. Keep away from fire or flame.
• For external use only.

do not use

• In the eyes

When Using

• Do not use in or near the eyes.
• If contact occurs, flush eyes with water for 15 minutes. Consult physician if irritation persists.
• If swallowed, seek medical assistance or consult a poison control center immediately.

Stop Use

• Stop use and ask a doctor if: Irritation develops. If condition persists for more than 72 hours consult a doctor.
• Keep out of reach of children.

• Keep out of reach of children.

Directions for Use

• Place a palmful ( 5 grams) of product in one hand,.
• Spread on both hands and rub into the skin until dry (approximately 1 to 2 minutes).
• Place a smaller amount (2.5 grams) into one hand, spread over both hands to wrist and rub into the skin until dry (approximately 30 seconds).
• Will air dry in 15 seconds.

• Store below 95 o F.
• Close spout to avoid evaporation.

Water, triethanolamine, fragrance, acrylic polymer

VINDICATOR - E 
vindicator - e liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 66608-693
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	67 mL  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
CARBOMER 940 (UNII: 4Q93RCW27E)
TROLAMINE (UNII: 9O3K93S3TK)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 66608-693-01	118 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	05/13/2020	07/01/2024
2	NDC: 66608-693-02	236 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	05/13/2020	09/01/2024

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	05/13/2020	09/01/2024

Labeler - Kimball Midwest (017906231)

Establishment
Name	Address	ID/FEI	Business Operations
QuestSpecialty Corporation		103840377	manufacture(66608-693)

Revised: 9/2022

Document Id: cc1f98fb-9f92-4e67-9eba-6a073f9bf489

34390-5

Set id: c195e01c-d59e-3ee7-e053-2a95a90a65a4

Version: 2

Effective Time: 20220915