HUSH ANESTHETIC- lidocaine gel

Hush Anesthetic by

Drug Labeling and Warnings

Hush Anesthetic by is a Otc medication manufactured, distributed, or labeled by HUSH Anesthetic. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredients

Lidocaine HCL 4% w/w

Purpose

Pain Relieving Liquid

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children

Uses

For the temporary relief of pain and itching associated with minor cuts or minor skin irritations

Directions

Adults and children 2 years of age or older: Apply to affected area not more than 3 to 4 times daily.  Children under 2 years of age; consult a physician.

Warnings

For external use only Avoid contact with eyes

STOP USE

Stop use and ask a doctor if condition worsens or if symptoms persist more than 7 days or clear up and occur again with a few days

DO NOT USE

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

Other Information

Protect this product from excessive heat and direct sun.

Inactive ingredients

Acrylates/c10-30 Alkyl Acrylate Crosspolymer, Aloe Barbadensis Leaf Extract, Aqua (Deionized Water), Calendula Officinale Extract, Caprylyl Glycol, Chamomile (Chamomile Recutita) Extract, Comfrey (Symphytum Officinale) Extract, Disodium EDTA, Glycerin, Green Tea (Camellia Sinensis) Extract, Menthol, Methylisothiazolinone, Propylene Glycol, SD Alcohol 40B, Triethanolamine

Questions or Comments?

Call 305-231-7229 or visit www.hushanesthetic.com

PRINCIPAL DISPLAY PANEL

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

HUSH ANESTHETIC 
lidocaine gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 49947-002
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
LIDOCAINE (UNII: 98PI200987) (LIDOCAINE - UNII:98PI200987)	LIDOCAINE	40 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
ALCOHOL (UNII: 3K9958V90M)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
TROLAMINE (UNII: 9O3K93S3TK)
GLYCERIN (UNII: PDC6A3C0OX)
MENTHOL (UNII: L7T10EIP3A)
CHAMAEMELUM NOBILE FLOWER (UNII: O2T154T6OG)
CALENDULA OFFICINALIS FLOWER (UNII: P0M7O4Y7YD)
GREEN TEA LEAF (UNII: W2ZU1RY8B0)
COMFREY ROOT (UNII: M9VVZ08EKQ)
CARBOMER INTERPOLYMER TYPE B (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 132584PQMO)
EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 49947-002-04	113.4 g in 1 BOTTLE; Type 0: Not a Combination Product	12/01/2012
2	NDC: 49947-002-02	56.7 g in 1 BOTTLE; Type 0: Not a Combination Product	12/01/2012

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part348	12/01/2012

Labeler - HUSH Anesthetic (012011309)