Aspercreme With Lidocaine Essential Oils Rosemary Mint

Aspercreme With Lidocaine Essential Oils Rosemary Mint
SPL v3
SPL
SPL Set ID 9c81d5eb-fa9b-47fb-8924-6ebf6a5c6bab
Route
TOPICAL
Published
Effective Date 2023-10-24
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Lidocaine (4 g)
Inactive Ingredients
Carbomer Interpolymer Type A (55000 Cps) Alcohol Aloe Vera Leaf Aminomethylpropanol Caprylyl Trisiloxane Cetostearyl Alcohol Ceteth-20 Phosphate Dimethicone Dihexadecyl Phosphate Ethylhexylglycerin Glyceryl Monostearate Hydroxyethyl Acrylate/sodium Acryloyldimethyl Taurate Copolymer (100000 Mpa.s At 1.5%) Isohexadecane Methylparaben Polysorbate 60 Water Steareth-21 Steareth-2 Edetate Disodium

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2021-01-01

Description

ASPERCREME LIDOCAINE WITH ROSEMARY MINT NO-MESS Drug Facts

Purpose

Topical anesthetic


Medication Information

Purpose

Topical anesthetic

Description

ASPERCREME LIDOCAINE WITH ROSEMARY MINT NO-MESS Drug Facts

In

acrylates/C10-30 alkyl acrylate crosspolymer, alcohol denat. (15%), aloe barbadensis leaf juice, aminomethyl propanol, C30-45 alkyl cetearyl dimethicone crosspolymer, caprylyl methicone, cetearyl alcohol, ceteth-20 phosphate, dicetyl phosphate, dimethicone, disodium EDTA, ethylhexylglycerin, glyceryl stearate, hydroxyethyl acrylate/sodium acryloyldimethyl taurate copolymer, isohexadecane, methylparaben, polysorbate 60, rosemary mint fragrance, steareth-2, steareth-21, water

Child-resistant packaging. Close cap tightly after use.

Use

temporarily relieves minor pain

Section 42229-5

ASPERCREME LIDOCAINE WITH ROSEMARY MINT NO-MESS

Drug Facts

Active I

Lidocaine HCl 4%

Warnings

For external use only

Directions

a dults and children over 12 years:

■ apply a thin layer to affected area not more than 3 to 4 times daily

children 12 years or younger : ask a doctor

Do Not Use

 on large areas of the body or on cut, irritated or swollen skin

■ on puncture wounds 

■ for more than one week without consulting a doctor 

Principal Display Panel

MAX STRENGTH

Aspercreme


with 4% LIDOCAINE


2.5 FL oz (73 mL)

When Using This Product

■ use only as directed. Read and follow all directions and warnings on this carton.

■ do not allow contact with the eyes and mucous membranes

■ do not bandage or apply local heat (such as heating pads) or a medicated patch to area of use

■ do not use at the same time as other topical analgesics  

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

Flammable  ■ Keep away from fire or flame

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.


Structured Label Content

In

acrylates/C10-30 alkyl acrylate crosspolymer, alcohol denat. (15%), aloe barbadensis leaf juice, aminomethyl propanol, C30-45 alkyl cetearyl dimethicone crosspolymer, caprylyl methicone, cetearyl alcohol, ceteth-20 phosphate, dicetyl phosphate, dimethicone, disodium EDTA, ethylhexylglycerin, glyceryl stearate, hydroxyethyl acrylate/sodium acryloyldimethyl taurate copolymer, isohexadecane, methylparaben, polysorbate 60, rosemary mint fragrance, steareth-2, steareth-21, water

Child-resistant packaging. Close cap tightly after use.

Use

temporarily relieves minor pain

Section 42229-5 (42229-5)

ASPERCREME LIDOCAINE WITH ROSEMARY MINT NO-MESS

Drug Facts

Purpose

Topical anesthetic

Active I (Active i)

Lidocaine HCl 4%

Warnings

For external use only

Directions

a dults and children over 12 years:

■ apply a thin layer to affected area not more than 3 to 4 times daily

children 12 years or younger : ask a doctor

Do Not Use (Do not use)

 on large areas of the body or on cut, irritated or swollen skin

■ on puncture wounds 

■ for more than one week without consulting a doctor 

Principal Display Panel (PRINCIPAL DISPLAY PANEL)

MAX STRENGTH

Aspercreme


with 4% LIDOCAINE


2.5 FL oz (73 mL)

When Using This Product (When using this product)

■ use only as directed. Read and follow all directions and warnings on this carton.

■ do not allow contact with the eyes and mucous membranes

■ do not bandage or apply local heat (such as heating pads) or a medicated patch to area of use

■ do not use at the same time as other topical analgesics  

Stop Use and Ask A Doctor If (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

Flammable  ■ Keep away from fire or flame

If Pregnant Or Breast Feeding, (If pregnant or breast-feeding,)

ask a health professional before use.

Keep Out of Reach of Children. (Keep out of reach of children.)

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


Advanced Ingredient Data


Raw Label Data

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