ASPERCREME LIDOCAINE WITH EUCALYPTUS ESSENTIAL OIL- lidocaine hcl cream
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 Lidocaine with Eucalyptus Essential Oil

Drug Facts

Active ingredient

Purpose

Lidocaine HCl 4%............................................................................................................................Topical anesthetic

Use

for the temporary relief of pain

Warnings

For external use only

Flammable: keep away from fire or flame.

Do not use

■ in large quantities

■ on wounds or on irritated or damaged skin

■ with a heating pad

When using this product

■ use only as directed

■ do not bandage tightly

■ avoid contact with eyes and mucous membranes

■ do not expose the area to local heat or to direct sunlight

Stop use and ask a doctor if

■ condition worsens or symptoms persist for more than 7 days

■ symptoms clear up and occur again within a few days

■ redness is present or excessive skin irritation occurs

■ you experience severe burning 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.

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

Directions

■ adults and children 12 years of age and older:

■ apply a thin layer to affected area every 6 to 8 hours, not more than 3 to 4 times daily

■ massage until thoroughly absorbed into skin

■ wash hands thoroughly with soap and water after each use

■ children under 12 years of age: ask a doctor

Inactive ingredients

alcohol denat. (15%), aloe barbadensis leaf juice, C15-19 alkane, caprylic/capric triglyceride, carbomer, cetearyl alcohol, citric acid, ethylhexylglycerin, eucalyptus globulus leaf oil, glycerin, glyceryl stearate, hydroxyacetophenone, potassium hydroxide, polysorbate 60, propanediol, steareth-2, steareth-21, water

373-005

Child-resistant packaging. Close cap tightly after use.

Keep carton as it contains important information.

PRINCIPAL DISPLAY PANEL

Aspercreme
Lidocaine with Eucalyptus Essential Oil
Numbs away pain
NET WT 3 oz (85 g)

PRINCIPAL DISPLAY PANEL
Aspercreme
Lidocaine with Eucalyptus Essential Oil
Numbs away pain
NET WT 3 oz (85 g)

ASPERCREME LIDOCAINE WITH EUCALYPTUS ESSENTIAL OIL
lidocaine hcl cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:41167-0566
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
LIDOCAINE HYDROCHLORIDE (UNII: V13007Z41A) (LIDOCAINE - UNII:98PI200987)	LIDOCAINE HYDROCHLORIDE ANHYDROUS	4 g in 100 g

Ingredient Name	Strength
Inactive Ingredients
ALOE VERA LEAF (UNII: ZY81Z83H0X)
C15-19 ALKANE (UNII: CI87N1IM01)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
CARBOXYPOLYMETHYLENE (UNII: 0A5MM307FC)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
EUCALYPTUS OIL (UNII: 2R04ONI662)
GLYCERIN (UNII: PDC6A3C0OX)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
HYDROXYACETOPHENONE (UNII: G1L3HT4CMH)
POTASSIUM HYDROXIDE (UNII: WZH3C48M4T)
POLYSORBATE 60 (UNII: CAL22UVI4M)
PROPANEDIOL (UNII: 5965N8W85T)
STEARETH-2 (UNII: V56DFE46J5)
STEARETH-21 (UNII: 53J3F32P58)
WATER (UNII: 059QF0KO0R)
ALCOHOL (UNII: 3K9958V90M)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:41167-0566-0	1 in 1 CARTON	01/15/2023
1		85 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part348	01/15/2023

Labeler - Chattem, Inc. (003336013)

Revised: 12/2022

Document Id: a93113cf-5261-49ac-92dc-2481c87710de

Set id: 03e247b4-a2e2-4354-a018-880f1bc987fd

Version: 1

Effective Time: 20221222

Chattem, Inc.