AMINO RIP MUSCLE PAIN RELIEF- lidocaine hcl liquid

Amino Rip Muscle Pain Relief by

Drug Labeling and Warnings

Amino Rip Muscle Pain Relief by is a Otc medication manufactured, distributed, or labeled by LLORENS PHARMACEUTICALS INTERNATIONAL DIVISION. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active Ingredients

Lidocaine HCl

PURPOSE

Purpose

Topical Anesthetic

INDICATIONS & USAGE

Use Temporarily relieves minor pains

WARNINGS

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 direct. Read and follow all directions and warnings on this label.

• Do not allow contact with eyes
• Do not bandage or apply local heat (such as heating pads) to the area of use.

Stop use and ask doctor if

• Condition worsens
• Symptoms persist for more than 7 days or clear up and occur again within a few days
• If pregnant or breast feeding, ask a doctor before use.
• Keep out of the reach of children
• If swallowed, get medical help or contact a Poison Control Center right away.

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children.

DOSAGE & ADMINISTRATION

Directions

• Adults and children over 12 years of age
• Apply generously to the affected area as needed every 6-8 hours, not to exceed 3 applications in a 24 hour period. Not for use in children under 12 years of age

INACTIVE INGREDIENT

Inactive ingredients

camphor, glycerin, isopropyl alcohol, menthol, methylparaben, propylparaben, purified water, xantham gum

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

AMINO RIP MUSCLE PAIN RELIEF 
lidocaine hcl liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 54859-415
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
LIDOCAINE (UNII: 98PI200987) (LIDOCAINE - UNII:98PI200987)	LIDOCAINE	4 mg  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET)
GLYCERIN (UNII: PDC6A3C0OX)
ISOPROPYL ALCOHOL (UNII: ND2M416302)
MENTHOL (UNII: L7T10EIP3A)
METHYLPARABEN (UNII: A2I8C7HI9T)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
WATER (UNII: 059QF0KO0R)
XANTHAN GUM (UNII: TTV12P4NEE)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 54859-415-02	60 mL in 1 BOTTLE; Type 0: Not a Combination Product	10/01/2019

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part348	10/01/2019

Labeler - LLORENS PHARMACEUTICALS INTERNATIONAL DIVISION (037342305)

Registrant - LLORENS PHARMACEUTICALS INTERNATIONAL DIVISION (037342305)

Establishment
Name	Address	ID/FEI	Business Operations
LLORENS PHARMACEUTICALS INTERNATIONAL DIVISION		037342305	manufacture(54859-415)