DOLOGESIC ROLL-ON- lidocaine hcl liquid

Dologesic Roll-On by

Drug Labeling and Warnings

Dologesic Roll-On by is a Otc medication manufactured, distributed, or labeled by Llorens Pharmaceutical International Division, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active Ingredient

Lidocaine HCL, USP 4% 

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 directed. 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

PREGNANCY OR BREAST FEEDING

If pregnant or breast-feeding, ask a doctor before use.

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

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 application 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 and xantham gum.

QUESTIONS

Questions

Llorens Pharmaceutical International Division, Inc.

Miami Fl 33147

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

DOLOGESIC ROLL-ON 
lidocaine hcl liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 54859-513
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 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: 54859-513-02	60 mL in 1 BOTTLE; Type 0: Not a Combination Product	05/01/2018

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part348	05/01/2018

Labeler - Llorens Pharmaceutical International Division, Inc. (037342305)