HUSH FAST ACTING TOPICAL ANESTHETIC - lidocaine gel
Hush Anesthetic

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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HUSH Fast Acting Topical Anesthetic Gel

Drug Facts

Active Ingredients

Lidocaine 4%

Purpose

Topical Anesthetic

Uses:

For the temporary relief of discomfort and pain associated with

minor burns and skin irritations
minor cuts and scrapes
itching

Warnings:

For external use only.

Avoid contact with eyes.

Do not use In large quantities, particularly over raw surfaces or blistered areas

Stop use and ask a doctor if

skin becomes irritated
condition worsens or symptoms last more than 7 days
symptoms clear up and reoccur within a few days

Keep out of reach of children

Directions

Adults and children 12 years of age or older: Apply to affected area not more than 3 to 4 times daily.

Other Ingredients:

Aloe Barbadensis Leaf Juice, Calendula Officinalis Flower Extract, Camellia Sinensis (Green Tea) Leaf Extract, Carbomer, Chamomilla Recutita (Matricaria) Flower Extract, Diazolidinyl Urea, Disodium EDTA, Glycerin, Menthol, Methylparaben, Propylene Glycol, Propylparaben, Purified Water, SD Alcohol 40-2, Symphytum Officinale (Comfrey) Leaf Extract, Triethanolamine

HUSH Fast Acting Topical Anesthetic Gel 2oz/60g

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HUSH FAST ACTING TOPICAL ANESTHETIC
lidocaine gel

Product Information
Product Type	HUMAN OTC DRUG LABEL	Item Code (Source)	NDC:49947-909
Route of Administration	TOPICAL	DEA Schedule

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
LIDOCAINE (LIDOCAINE)	LIDOCAINE	4 g in 100 g

Ingredient Name	Strength
Inactive Ingredients
ALOE VERA LEAF
CALENDULA OFFICINALIS FLOWER
GREEN TEA LEAF
CHAMOMILE
DIAZOLIDINYL UREA
EDETATE DISODIUM
GLYCERIN
MENTHOL
METHYLPARABEN
PROPYLENE GLYCOL
PROPYLPARABEN
WATER
ALCOHOL
COMFREY LEAF
TROLAMINE

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:49947-909-02	60 g in 1 BOTTLE

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part348	04/04/2012

Labeler - Hush Anesthetic (012011309)

Registrant - Filltech USA, LLC (965596435)

Name	Address	ID/FEI	Business Operations
Establishment
Filltech USA, LLC		965596435	manufacture

Revised: 4/2012

Document Id: 3e319f79-b8c2-4813-b68d-18341ccd6be6

Set id: 2bf398a5-d4c0-4d1f-b3b6-2c583bfe79cc

Version: 1

Effective Time: 20120404

Hush Anesthetic