WESTLAKE OUTDOOR PAIN AND ITCH RELIEVING- lidocaine 4% pain and itch relieving cream

Westlake Outdoor Pain and Itch Relieving by

Drug Labeling and Warnings

Westlake Outdoor Pain and Itch Relieving by is a Otc medication manufactured, distributed, or labeled by WESTLAKE HB PHARMA, Weeks & Leo Co. Inc., Weeks & Leo Co., Inc. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

PURPOSE

Topical analgesic

ACTIVE INGREDIENT

Lidocaine HCl 4%

ASK DOCTOR

• Condition gets worse
• symptoms last for more than 7 days
• symptoms clear up and occur again within a few days

DO NOT USE

• in large quantities, particularly over raw surface or blistered areas

KEEP OUT OF REACH OF CHILDREN

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

QUESTIONS

questions@westlakepharma.com

817-721-6844

WARNINGS

For external use onlyy

INSTRUCTIONS FOR USE

• adults and children 2 years and over: apply to affected area not more than 3 to 4 times daily
• children under 2 years: ask a doctor

STORAGE AND HANDLING

store between 20ºC and 25ºC (68ºF and 77ºF)

WHEN USING

do not get into eyes

INDICATIONS & USAGE

• temporarily relieves pain and itching due to:
  • minor burns
  • sun burns
  • minor cuts
  • scrapes
  • insect bite
  • minor skin irritations

DOSAGE & ADMINISTRATION

apply to affected area not more than 3 to 4 times daily

INACTIVE INGREDIENT

acrylates/C10-30 alkyl acrylate crosspolymer, aloe barbadensis (aleo vera) leaf juice, aminomethyl propanol, C30-45 alkyl cetearyl dimethicone crosspolymer, caprylyl methicone, cetearyl alcohol, ceteth-30 phosphate, dicetyl phoshpate, dimethicone, edetate disodium, ethylhexylglycerin, glyceryl monosterate, methylparaben, purified water, SD alcohol 40, steareth-21

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

WESTLAKE OUTDOOR PAIN AND ITCH RELIEVING 
lidocaine 4% pain and itch relieving cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 82895-718
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
LIDOCAINE HYDROCHLORIDE (UNII: V13007Z41A) (LIDOCAINE - UNII:98PI200987)	LIDOCAINE HYDROCHLORIDE ANHYDROUS	40 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)
CETETH-20 PHOSPHATE (UNII: 921FTA1500)
GLYCERYL STEARATE (UNII: 230OU9XXE4)
AMINOMETHYL PROPANOL (UNII: LU49E6626Q)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
CAPRYLYL METHICONE (UNII: Q95M2P1KJL)
STEARETH-21 (UNII: 53J3F32P58)
DIMETHICONE 350 (UNII: 2Y53S6ATLU)
ALCOHOL (UNII: 3K9958V90M)
METHYLPARABEN (UNII: A2I8C7HI9T)
CETEARYL ALCOHOL (UNII: 2DMT128M1S)
C30-45 ALKYL CETEARYL DIMETHICONE CROSSPOLYMER (UNII: 4ZK9VP326R)
ALOE BARBADENSIS LEAF JUICE (UNII: RUE8E6T4NB)
ACRYLATES/C10-30 ALKYL ACRYLATE CROSSPOLYMER (60000 MPA.S) (UNII: 8Z5ZAL5H3V)
WATER (UNII: 059QF0KO0R)

Product Characteristics
Color	white	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 82895-718-50	49 g in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	07/01/2025

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M017	07/01/2025

Labeler - WESTLAKE HB PHARMA (081176855)

Registrant - Weeks & Leo Co. Inc. (005290028)

Establishment
Name	Address	ID/FEI	Business Operations
Weeks & Leo Co., Inc		005290028	manufacture(82895-718)