Restoriden Lidocaine Pain Relief Cream

Restoriden Lidocaine Pain Relief Cream
SPL v1
SPL
SPL Set ID b20e8649-9459-a9cb-e053-2a95a90ab31c
Route
TOPICAL
Published
Effective Date 2020-10-20
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

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

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2020-10-20

Description

Restoriden Nutrition 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

Restoriden Nutrition LIDOCAINE PAIN RELIEF CREAM

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

PRODUCT LABEL

AND PRODUCT 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

Restoriden Nutrition 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 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)

PRODUCT LABEL

AND PRODUCT 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)

Restoriden Nutrition LIDOCAINE PAIN RELIEF CREAM


Advanced Ingredient Data


Raw Label Data

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