Dologesic Roll-on 513

Dologesic Roll-on 513
SPL v9
SPL
SPL Set ID 81546810-85a8-45fe-b9e6-cdd02cc4c080
Route
TOPICAL
Published
Effective Date 2020-12-23
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Inactive Ingredients
Camphor (synthetic) Glycerin Isopropyl Alcohol Menthol Methylparaben Propylparaben Water Xanthan Gum

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2018-05-01
Description

Active Ingredient Lidocaine HCL, USP 4% 

Medication Information

Warnings and Precautions

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
Indications and Usage

Use

Temporarily relieves minor pains

Dosage and 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.
Description

Active Ingredient Lidocaine HCL, USP 4% 

Section 50565-1

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

Section 51727-6

Inactive ingredients

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

Section 51945-4

Section 53413-1

Questions

Llorens Pharmaceutical International Division, Inc.

Miami Fl 33147

Section 53414-9

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

Section 55105-1

Purpose

Topical Anesthetic

Section 55106-9

Active Ingredient

Lidocaine HCL, USP 4% 

Structured Label Content

Indications and Usage (34067-9)

Use

Temporarily relieves minor pains

Dosage and Administration (34068-7)

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.
Warnings and Precautions (34071-1)

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
Section 50565-1 (50565-1)

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

Section 51727-6 (51727-6)

Inactive ingredients

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

Section 51945-4 (51945-4)

Section 53413-1 (53413-1)

Questions

Llorens Pharmaceutical International Division, Inc.

Miami Fl 33147

Section 53414-9 (53414-9)

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

Section 55105-1 (55105-1)

Purpose

Topical Anesthetic

Section 55106-9 (55106-9)

Active Ingredient

Lidocaine HCL, USP 4% 

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:08:01.257088 · Updated: 2026-03-14T23:12:08.624404