Restore By Pure Research Pain Relief Cream

Restore By Pure Research Pain Relief Cream
SPL v1
SPL
SPL Set ID c24df35c-2c81-2fe6-e053-2995a90afb59
Route
TOPICAL
Published
Effective Date 2021-05-05
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Inactive Ingredients
Hexylene Glycol Hippophae Rhamnoides Seed Oil Water White Wax Medium-chain Triglycerides Propylene Glycol Jojoba Oil Cetostearyl Alcohol Arnica Montana Flower Caprylyl Glycol Ethylhexylglycerin Stearic Acid Tocopherol Polysorbate 20 Hippophae Rhamnoides Fruit Oil Glycerin Phenoxyethanol Sodium Hydroxide Edetate Sodium

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2021-05-05

Description

Restore By Pure Research LIDOCAINE PAIN RELIEF CREAM


Medication Information

Warnings and Precautions

For External Use only

Indications and Usage

Uses: to reduce pain or discomfort caused by skin irritations such as sunburn, insect bites, poison ivy, poison oak, poison sumac, and minor cuts, scratches or burns.

Dosage and Administration

Directions: adults and children 2 years and older apply externally to the affected area up to 3 to 4 times a day

Children under 2 years, ask a doctor

Description

Restore By Pure Research LIDOCAINE PAIN RELIEF CREAM

Section 43683-2

The only changes in this submission are the product name and a new effective date.

Section 50565-1

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

Section 50566-9

Stop Use and ask a doctor if:

  • allergic reaction occurs
  • condition worsens or does not improve within 7 days
  • symptoms clear up and return within a few days
  • redness, irritation, swelling, pain or other symptoms begin.
Section 50567-7

When using this product, do not use in or near the eyes

  • do not use in large quantities, particularly over raw surfaces or blistered areas.
Section 51727-6

Arnica Montana Extract, Capryl Glycol, Caprylic/Capric Triglycerides, Cetearyl Alcohol, Deionized Water, Emulsifying Wax NF, Ethylhexylglycerin, Glycerin,Hexylene Glycol, Hippophae Rhamnoides Fruit and Seed Oils, Phenoxyethanol, Polysorbate 20, Propylene Glycol, Simmondsia Chinensis (Jojoba) Seed Oil, Sodium Hydroxide, Stearic Acid, Tetrasodium EDTA, Tocopherol

Section 51945-4

RESTORE JAR LABEL AND

RESTORE BOX

Section 53413-1
Section 55105-1

Purpose

Topical anesthetic

Section 55106-9

Lidocaine HCl 4%

Section 60561-8

May be applied under occlusive dressing

Store at 20 - 25° C

Section 69718-5

Restore By Pure Research LIDOCAINE PAIN RELIEF CREAM


Structured Label Content

Indications and Usage (34067-9)

Uses: to reduce pain or discomfort caused by skin irritations such as sunburn, insect bites, poison ivy, poison oak, poison sumac, and minor cuts, scratches or burns.

Dosage and Administration (34068-7)

Directions: adults and children 2 years and older apply externally to the affected area up to 3 to 4 times a day

Children under 2 years, ask a doctor

Warnings and Precautions (34071-1)

For External Use only

Section 43683-2 (43683-2)

The only changes in this submission are the product name and a new effective date.

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 50566-9 (50566-9)

Stop Use and ask a doctor if:

  • allergic reaction occurs
  • condition worsens or does not improve within 7 days
  • symptoms clear up and return within a few days
  • redness, irritation, swelling, pain or other symptoms begin.
Section 50567-7 (50567-7)

When using this product, do not use in or near the eyes

  • do not use in large quantities, particularly over raw surfaces or blistered areas.
Section 51727-6 (51727-6)

Arnica Montana Extract, Capryl Glycol, Caprylic/Capric Triglycerides, Cetearyl Alcohol, Deionized Water, Emulsifying Wax NF, Ethylhexylglycerin, Glycerin,Hexylene Glycol, Hippophae Rhamnoides Fruit and Seed Oils, Phenoxyethanol, Polysorbate 20, Propylene Glycol, Simmondsia Chinensis (Jojoba) Seed Oil, Sodium Hydroxide, Stearic Acid, Tetrasodium EDTA, Tocopherol

Section 51945-4 (51945-4)

RESTORE JAR LABEL AND

RESTORE BOX

Section 53413-1 (53413-1)
Section 55105-1 (55105-1)

Purpose

Topical anesthetic

Section 55106-9 (55106-9)

Lidocaine HCl 4%

Section 60561-8 (60561-8)

May be applied under occlusive dressing

Store at 20 - 25° C

Section 69718-5 (69718-5)

Restore By Pure Research LIDOCAINE PAIN RELIEF CREAM


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)