ASPERCREME- lidocaine patch

Aspercreme by

Drug Labeling and Warnings

Aspercreme by is a Otc medication manufactured, distributed, or labeled by Lead Chemical Co. Ltd.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredient

Lidocaine 4%

Purpose

Topical Anesthetic

Uses

Temporarily relieves minor pain

Warnings

For external use only

Do Not Use

• more than 1 patch on your body at a time or on cut, irritated or swollen skin
• on puncture wounds
• for more than one week without consulting a doctor

When Using This Product

• use only as directed. Read and follow all directions and warnings on this label.
• do not allow contact with the eyes
• do not bandage tightly or apply local heat (such as heating pads) to the area of use
• do not use at the same time as other topical analgesics
• dispose of used patch in manner that always keeps product away from children or pets. Used patches still contain the drug product that can produce serious adverse effects if a child or pet chews or ingests this patch.

Stop Use and Ask a Doctor if

• condition worsens
• redness is present
• irritation develops
• symptoms persist for more than 7 days or clear up and occur again within a few days
• you experience signs of skin injury, such as pain, swelling, or blistering where the product was applied

If Pregnant or Breast Feeding

ask a health professional before use.

Keep Out of Reach of Children and Pets

If swallowed, get medical help or contact a Poison Control Center right away.

Directions

Adults and children over 12 years:

• clean and dry affected area
• remove backing from patch by firmly grasping both ends and gently pulling until backing separates in middle
• carefully remove smaller portion of backing from patch and apply exposed portion of patch to affected area
• once exposed portion of patch is positioned, carefully remove remaining backing to completely apply patch to affected area
• use 1 patch for up to 12 hours

children 12 years or younger: ask a doctor

Inactive Ingredients

aluminum glycinate, aluminum hydroxide, cellulose gum, glycerin, methylparaben, polyacrylic acid, polysorbate 80, propylene glycol, silica, sodium polyacrylate, tartaric acid, titanium dioxide, urea, water (333-030)

Package/Label Principal Display Panel

MAX STRENGTH LIDOCAINE

ODOR FREE
Aspercreme®
LIDOCAINE PATCH
THE NUMBER ONE ODOR FREE CREME BRAND

NUMBS
AWAY PAIN

• Desensitizes
  Aggravated Nerves
• Fact Acting
• Targets More
  Pain Receptors*
• Non Irritating

Contains 1 Patch
3-15/16” x 5-1/2” (10 cm x 14 cm) each

Pain Relieving Ointment on
a Breathable Adhesive Pad
4% Lidocaine

Label

INGREDIENTS AND APPEARANCE

ASPERCREME 
lidocaine patch

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 62168-0584
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
LIDOCAINE (UNII: 98PI200987) (LIDOCAINE - UNII:98PI200987)	LIDOCAINE	246 mg

Inactive Ingredients
Ingredient Name	Strength
DIHYDROXYALUMINUM AMINOACETATE ANHYDROUS (UNII: 1K713C615K)
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM (UNII: K679OBS311)
GLYCERIN (UNII: PDC6A3C0OX)
METHYLPARABEN (UNII: A2I8C7HI9T)
POLYSORBATE 80 (UNII: 6OZP39ZG8H)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
TARTARIC ACID (UNII: W4888I119H)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
UREA (UNII: 8W8T17847W)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 62168-0584-0	810 in 1 CARTON	02/16/2016	02/28/2018
1		1 in 1 POUCH; Type 0: Not a Combination Product
2	NDC: 62168-0584-1	1 in 1 POUCH; Type 0: Not a Combination Product	08/01/2016
3	NDC: 62168-0584-2	400 in 1 CARTON	05/10/2016
3		1 in 1 POUCH; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part348	02/16/2016

Labeler - Lead Chemical Co. Ltd. (693727091)

Registrant - Lead Chemical Co. Ltd. (693727091)

Establishment
Name	Address	ID/FEI	Business Operations
Lead Chemical Co. Ltd.		693727091	ANALYSIS(62168-0584) , MANUFACTURE(62168-0584)

Establishment
Name	Address	ID/FEI	Business Operations
Lead Chemical Co. Ltd.		718216992	MANUFACTURE(62168-0584)