SPL v2
SPL
SPL Set ID 09835640-55c3-4bfa-9ad3-15d37f06e871
Route
TOPICAL
Published
Effective Date 2016-09-14
Document Type 34391-3 HUMAN PRESCRIPTION DRUG LABEL

Drug Facts

Composition & Product

Inactive Ingredients
Water C13-14 Isoparaffin Glyceryl Monostearate Helianthus Annuus Flowering Top Isopropyl Myristate Laureth-7 Methylisothiazolinone Stearic Acid

Identifiers & Packaging

Marketing Status
UNAPPROVED DRUG OTHER Active Since 2016-06-07

Description

Drug Facts

Purpose

External Anesthetic


Medication Information

Purpose

External Anesthetic

Description

Drug Facts

Uses

For temporary relief of pain and itching and minor skin irritations due to minor cuts and scrapes, sunburns, and minor burns.

Section 42229-5

Drug Facts

Section 50565-1

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

Warning

For external use only.

Avoid contact with eyes

Directions

For adults and children two-years or older, apply externally to the affected area. Do not use more than three to four times per day.

Active Ingredients

Lidocaine HCI 4%

Inactive Ingredients

Inactive ingredients: Aqua (Deionized Water), C13-14 Isoparaffin, Glyceryl Stearate, Helianthus Annuus (Sunflower) Seed Oil, Isopropyl Myristate, Laureth-7, M Polyacrylamide, Steric Acid.

Stop Using This Product and Ask Doctor If
  • symptoms last for more than seven days, or clear up and occur again within a few days
  • if redness, irritation, swelling, pain or other symptoms increase
Principal Display Panel 88 Ml Bottle Label

‘Eha Lotion 4%

Pain Relief Lotion

For Professional Use Only

3 OZ (88 mL)

Distributed by

Enovachem

PHARMACEUTICALS

Torrance, CA 90501

(310) 320-0100


Structured Label Content

Uses

For temporary relief of pain and itching and minor skin irritations due to minor cuts and scrapes, sunburns, and minor burns.

Section 42229-5 (42229-5)

Drug Facts

Section 50565-1 (50565-1)

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

Purpose

External Anesthetic

Warning

For external use only.

Avoid contact with eyes

Directions

For adults and children two-years or older, apply externally to the affected area. Do not use more than three to four times per day.

Active Ingredients

Lidocaine HCI 4%

Inactive Ingredients (Inactive ingredients)

Inactive ingredients: Aqua (Deionized Water), C13-14 Isoparaffin, Glyceryl Stearate, Helianthus Annuus (Sunflower) Seed Oil, Isopropyl Myristate, Laureth-7, M Polyacrylamide, Steric Acid.

Stop Using This Product and Ask Doctor If (Stop using this product and ask doctor if)
  • symptoms last for more than seven days, or clear up and occur again within a few days
  • if redness, irritation, swelling, pain or other symptoms increase
Principal Display Panel 88 Ml Bottle Label (Principal Display Panel - 88 mL Bottle Label)

‘Eha Lotion 4%

Pain Relief Lotion

For Professional Use Only

3 OZ (88 mL)

Distributed by

Enovachem

PHARMACEUTICALS

Torrance, CA 90501

(310) 320-0100


Advanced Ingredient Data


Raw Label Data

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