FORMULA 4 PAIN by Lifequest Creations LLC

FORMULA 4 PAIN by

Drug Labeling and Warnings

FORMULA 4 PAIN by is a Otc medication manufactured, distributed, or labeled by Lifequest Creations LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

FORMULA 4 PAIN- lidocaine hcl, menthol cream 
Lifequest Creations LLC

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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Active Ingredients                Purpose

Lidocaine HCl 4%                  Topical Anesthetic

Menthol 2%                          Topical Analgesic

Uses

Fast Pain Relief

Warnings

FOR EXTERNAL USE ONLY. NOT INTENDED FOR INGESTION DONT USE ONLARGE AREAS OF THE BODY OR ON CUT, IRRITATED OR SWOLLEN SKIN. Use only as directed, avoid contact with eyes and mucus membranes If pregnant or breast-feeding, ask a health care professional before use. If swallowed, get medical help

Direction

Apply topically to area and rub in. Repeate as needed.

Inactive ingredients

Purified water, Olive Oil, Shae Butter, Mango Butter, Hemp seed oil, Emulsifying wax, Stearic Acid, Palma rosa, Tea Tree, Eucalyptus, Camphor, Lavender, Ginger, Capsicum, Ale vera, Optiphen,  Arnica

Other information

Great for : Sore muscles, aching joints, gout flare-ups and body pain and other sports related pain.

Lidocaine helps alleviate stiffness, inflammation, joint pain, muscle soreness and more. Hemp seed oil allows ingredients to cross and absorb into

the skin. Menthol crystals gives instant cooling and pain releif. Physician formulated combined with other ingredients 4F pain cream is a great way

to control discomfort. Great before and after workouts.

Product label

FORMULA 4 PAIN 
lidocaine hcl, menthol cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 58292-003
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
LIDOCAINE HYDROCHLORIDE (UNII: V13007Z41A) (LIDOCAINE - UNII:98PI200987)	LIDOCAINE HYDROCHLORIDE ANHYDROUS	4 g  in 100 g
MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A) (MENTHOL, UNSPECIFIED FORM - UNII:L7T10EIP3A)	MENTHOL, UNSPECIFIED FORM	2 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
OLIVE OIL (UNII: 6UYK2W1W1E)
SHEA BUTTER (UNII: K49155WL9Y)
MANGO (UNII: I629I3NR86)
CANNABIS SATIVA SEED OIL (UNII: 69VJ1LPN1S)
.ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
PALMAROSA OIL (UNII: 0J3G3O53ST)
TEA TREE OIL (UNII: VIF565UC2G)
EUCALYPTUS OIL (UNII: 2R04ONI662)
CAMPHOR (NATURAL) (UNII: N20HL7Q941)
LAVENDER OIL (UNII: ZBP1YXW0H8)
GINGER OIL (UNII: SAS9Z1SVUK)
CAPSICUM OLEORESIN (UNII: UW86K581WY)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
ARNICA MONTANA WHOLE (UNII: O80TY208ZW)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 58292-003-01	113 g in 1 JAR; Type 0: Not a Combination Product	05/07/2023	05/07/2023

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part348	05/07/2023	05/07/2023

Labeler - Lifequest Creations LLC (053654857)

Establishment
Name	Address	ID/FEI	Business Operations
Lifequest Creations LLC		053654857	manufacture(58292-003)

Revised: 7/2023

Document Id: 003c0182-8262-d37d-e063-6294a90af2ff

34390-5

Set id: 433e2b4b-2add-4090-894e-38d82a8be519

Version: 2

Effective Time: 20230711