LBRI STOP THE PAIN SUPER ALOE PAIN RELIEF CREAM- menthol, methyl salicylate cream

LBRI STOP THE PAIN Super Aloe Pain Relief Cream by

Drug Labeling and Warnings

LBRI STOP THE PAIN Super Aloe Pain Relief Cream by is a Otc medication manufactured, distributed, or labeled by L'BRI HEALTH AND BEAUTY INC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

DRUG FACTS:

Active Ingredients

Menthol 5.00%

Methyl Salicylate 10.00%

Purpose

Topical Analgesic

Uses:

For the temporary relief of minor aches and pains of muscles and joints, associated with simple backache, arthritis, strains, bruises, and sprains.

Warnings:

For external use only.

Do not use

• on damaged or broken skin.

When using this product

• Do not bandage tightly.
• Avoid Contact with eyes.

Stop use and ask a doctor if

rash or irritation develops and lasts. condition worsens, or if symptoms persist for more than 7 days or clear up and occur again within a few days.

Keep out of reach of children.

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

If pregnant or breast-feeding,

ask a health professional before use.

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:

• Protect the product in this container from excessive heat and direct sun.

Inactive ingredients:

a-Bisabolol, Allantoin, Aloe Barbadensis Leaf (Aloe Vera Gel) Juice, Aqua (Deionized Water), Arnica Montana Flower Extract, Calendula Officinalis Extract, Caprylic/Capric Triglyceride, Capsaicin, Carbomer, Cetearyl Alcohol, Ceteareth-20, Ethylhexylglycerin, Eucalyptus Globulus Oil, Euterpe Oleracea (Acai Berry) Fruit Extract, Glucosamine sulfate, Glycerin, Glyceryl Stearate, Magnesium Sulfate, Malus Domestica (Apple) Fruit Cell Culture Extract, Mentha Piperita (Peppermint) Oil, Methylsulfonylmethane (MSM), PEG-100 Stearate, Phenoxyethanol, Polysorbate-20, Rosmarinus Officinalis (Rosemary) Extract, Stearic Acid, Symphytum Offiinale (Comfrey) Extract, Tocopheryl Acetate (Vitamin E), Triethanolamine, ZIngiber Officinalis (Ginger) Extract.

Package Labeling:

Package Labeling:

INGREDIENTS AND APPEARANCE

LBRI STOP THE PAIN SUPER ALOE PAIN RELIEF CREAM 
menthol, methyl salicylate cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 71238-492
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL	50 mg  in 1 mL
METHYL SALICYLATE (UNII: LAV5U5022Y) (SALICYLIC ACID - UNII:O414PZ4LPZ)	METHYL SALICYLATE	100 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
MAGNESIUM SULFATE, UNSPECIFIED FORM (UNII: DE08037SAB)
APPLE (UNII: B423VGH5S9)
PEPPERMINT OIL (UNII: AV092KU4JH)
DIMETHYL SULFONE (UNII: 9H4PO4Z4FT)
PEG-100 STEARATE (UNII: YD01N1999R)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
POLYSORBATE 20 (UNII: 7T1F30V5YH)
ROSEMARY (UNII: IJ67X351P9)
STEARIC ACID (UNII: 4ELV7Z65AP)
SYMPHYTUM X UPLANDICUM LEAF (UNII: D05HXK6R3G)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
TROLAMINE (UNII: 9O3K93S3TK)
GINGER (UNII: C5529G5JPQ)
ALLANTOIN (UNII: 344S277G0Z)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
WATER (UNII: 059QF0KO0R)
ARNICA MONTANA FLOWER (UNII: OZ0E5Y15PZ)
CALENDULA OFFICINALIS FLOWER (UNII: P0M7O4Y7YD)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
CAPSAICIN (UNII: S07O44R1ZM)
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
POLYOXYL 20 CETOSTEARYL ETHER (UNII: YRC528SWUY)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
EUCALYPTUS OIL (UNII: 2R04ONI662)
ACAI (UNII: 46AM2VJ0AW)
GLUCOSAMINE SULFATE (UNII: 1FW7WLR731)
GLYCERIN (UNII: PDC6A3C0OX)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 71238-492-00	118 mL in 1 TUBE; Type 0: Not a Combination Product	06/19/2023
2	NDC: 71238-492-01	5 mL in 1 PACKET; Type 0: Not a Combination Product	06/19/2023

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M015	06/19/2023

Labeler - L'BRI HEALTH AND BEAUTY INC (139751148)