PAIN RELIEF CREAM MAX STRENGTH (81310-001-27)

PAIN RELIEF MAX STRENGTH by

Drug Labeling and Warnings

PAIN RELIEF MAX STRENGTH by is a Otc medication manufactured, distributed, or labeled by STRETTON ONLINE LTD.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

PAIN RELIEF MAX STRENGTH- lidocaine, menthol cream 
STRETTON ONLINE LTD.

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PAIN RELIEF CREAM MAX STRENGTH (81310-001-27)

Drug Facts

Active Ingredient

Lidocaine HCI 4%
Menthol 1%

Purpose

Topical Analgesic

Uses

For the temporary relief of pain and/or itching associated with minor burns, sunburn, minor cuts, scrapes andinsect bites or minor skin irritations

Warnings

for external use only.

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

When Using this product

• use only as directed. Read and follow all directions and
• warnings on this carton.
• Warnings
• When using this product
• Do not use
• For external use only.
• 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
• rare cases of serious burns have been reported with products of this type
• if the condition worsens, or if symptoms persist for more than 7 days or clear up and occur again within a few days,
• discontinue use of this product and consult a doctor.
• do not bandage tightly or apply local heat (such as heating pads) to the area of use or use with a medicated patch
• a transient burning sensation may occur upon application but generally disappears in several days
• avoid contact with eyes
• avoid contact with mucous membranes
• do not use in large quantities, particularly over raw surfaces or blistered areas.

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

Keep out of reach of children

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

Directions

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

Other Information

• store at room temperature
• avoid direct sunlight

Inactive Ingredients

acrylates/C10-30 alkyl acrylate crosspolymer, 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, methylparaben, SD alcohol 40, steareth-21, water (309-124)

Questions

Child-resistant packaging.
Close cap tightly between uses.

Stretton Online Ltd
2160 Union Place
Simi Valley
CA 93065
United States
Medcosa.com
info@medcosa.com
+ 1 (562) 337-0165

Principal Display Panel (Labels)

Pain Relief Cream Max Strength (2.7 oz) NDC: 81310-001-27

Bottle:

Box:

PAIN RELIEF MAX STRENGTH 
lidocaine, menthol cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 81310-001
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
LIDOCAINE (UNII: 98PI200987) (LIDOCAINE - UNII:98PI200987)	LIDOCAINE	4 g  in 100 g
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL	1 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
ALOE VERA LEAF (UNII: ZY81Z83H0X)
CAPRYLYL TRISILOXANE (UNII: Q95M2P1KJL)
DIMETHICONE (UNII: 92RU3N3Y1O)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
WATER (UNII: 059QF0KO0R)
CETETH-20 PHOSPHATE (UNII: 921FTA1500)
EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)
METHYLPARABEN (UNII: A2I8C7HI9T)
ALCOHOL (UNII: 3K9958V90M)
DIHEXADECYL PHOSPHATE (UNII: 2V6E5WN99N)
GLYCERYL STEARATE SE (UNII: FCZ5MH785I)
STEARETH-21 (UNII: 53J3F32P58)
CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO)
AMINOMETHYLPROPANOL (UNII: LU49E6626Q)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 81310-001-27	1 in 1 BOX	01/27/2021
1		76.5 g in 1 BOTTLE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M017	01/27/2021	12/21/2023

Labeler - STRETTON ONLINE LTD. (220633327)

Revised: 12/2023

Document Id: 0d0b73d5-a42f-d939-e063-6394a90aae57

34390-5

Set id: b9ed380c-296d-3ab4-e053-2a95a90a4251

Version: 3

Effective Time: 20231221