ASPERCREME WITH LIDOCAINE XL

Main information

  • Trade name:
  • ASPERCREME WITH LIDOCAINE XL- lidocaine patch
  • Composition:
  • LIDOCAINE 422 mg
  • Administration route:
  • TOPICAL
  • Prescription type:
  • OTC DRUG
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • ASPERCREME WITH LIDOCAINE XL- lidocaine patch
    United States
  • Language:
  • English

Therapeutic information

  • Therapeutic indications:
  • Topical anesthetic temporarily relieves minor pain

Status

  • Source:
  • DailyMed - NLM - National Library of Medicine
  • Authorization status:
  • OTC monograph not final
  • Authorization number:
  • 41167-0585-0, 41167-0585-1
  • Last update:
  • 31-05-2019

Summary of Product characteristics: dosage, interactions, side effects

ASPERCREME WITH LIDOCAINE XL- lidocaine patch

Chattem, Inc.

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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Aspercreme with Lidocaine Patch XL

ASPERCREME LIDOCAINE PATCH XL

Drug Facts

Active ingredient

Lidocaine 4%

Purpose

Topical anesthetic

Use

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 carton/label. (change as

appropriate)

do not allow contact with the eyes and mucous membranes

■ 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 and 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

PRINCIPAL DISPLAY PANEL

Aspercreme

Lidocaine

Patch XL

ASPERCREME WITH LIDOCAINE XL

lidocaine patch

Product Information

Product T ype

HUMAN OTC DRUG

Ite m Code (Source )

NDC:4116 7-0 58 5

Route of Administration

TOPICAL

Active Ingredient/Active Moiety

Ingredient Name

Basis of Strength

Stre ng th

LIDO CAINE (UNII: 9 8 PI20 0 9 8 7) (LIDOCAINE - UNII:9 8 PI20 0 9 8 7)

LIDOCAINE

422 mg

Inactive Ingredients

Ingredient Name

Stre ng th

DIHYDRO XYALUMINUM AMINO ACETATE ANHYDRO US (UNII: 1K713C6 15K)

ALUMINUM HYDRO XIDE (UNII: 5QB0 T2IUN0 )

CARBO XYMETHYLCELLULO SE SO DIUM (UNII: K6 79 OBS311)

GLYCERIN (UNII: PDC6 A3C0 OX)

METHYLPARABEN (UNII: A2I8 C7HI9 T)

PO LYGALIC ACID (UNII: XCC6 WEA55L)

PO LYSO RBATE 8 0 (UNII: 6 OZP39 ZG8 H)

Chattem, Inc.

PRO PYLENE GLYCO L (UNII: 6 DC9 Q16 7V3)

SILICO N DIO XIDE (UNII: ETJ7Z6 XBU4)

SO DIUM PO LYACRYLATE ( 8 0 0 0 MW) (UNII: 28 5CYO341L)

TARTARIC ACID (UNII: W48 8 8 I119 H)

TITANIUM DIO XIDE (UNII: 15FIX9 V2JP)

UREA (UNII: 8 W8 T178 47W)

WATER (UNII: 0 59 QF0 KO0 R)

Packag ing

#

Item Code

Package Description

Marketing Start Date

Marketing End Date

1

NDC:4116 7-0 58 5-1

4 in 1 CARTON

10 /21/20 17

1

1 in 1 POUCH; Type 0 : No t a Co mbinatio n Pro duct

2

NDC:4116 7-0 58 5-0

3 in 1 CARTON

10 /21/20 17

2

1 in 1 POUCH; Type 0 : No t a Co mbinatio n Pro duct

Marketing Information

Marke ting Cate gory

Application Numbe r or Monograph Citation Marke ting Start Date

Marke ting End Date

OTC MONOGRAPH NOT FINAL part348

10 /21/20 17

Labeler -

Chattem, Inc. (003336013)

Revised: 10/2017