Recovery Numb Cream

Recovery Numb Cream
SPL v6
SPL
SPL Set ID e95e38e3-f743-4f5c-abdf-99ba6856e6f7
Route
TOPICAL
Published
Effective Date 2020-01-09
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Lidocaine (4 g)
Inactive Ingredients
Benzyl Alcohol Carbomer 940 Cholesterol Lecithin, Soybean Polysorbate 80 Propylene Glycol .alpha.-tocopherol Acetate, Dl- Trolamine Water

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2019-12-10

Description

DRUG FACTS


Medication Information

Warnings and Precautions

WARNINGS: FOR EXTERNAL USE ONLY.

Indications and Usage

Uses: Temporarily relieves pain and itching

due to minor cuts, minor scrapes, sunburn,

minor skin irritations, minor burns, insect bites.

Dosage and Administration

Directions: Adults and children 2 years and

older: Apply externally to the affected area up

to 3-4 times daily.

Children under 2 years of age: Consult a

doctor.

Description

DRUG FACTS

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

Section 50566-9

Stop use and ask 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 or increase.

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

Inactive ingredients: Benzyl Alcohol,

Carbomer 940, Cholesterol, Hydrogenated

Lecithin, Polysorbate 80, Propylene Glycol,

Tocopherol Acetate, Trolamine, Water

Section 55105-1

Purpose: Topical Anesthetic

Section 55106-9

Active Ingredients: Lidocaine 4% w/w

Section 60561-8

Other Information: Store at room

temperature 20°C and 25°C (68°F to

77°F).

Package Label

NUMB

CREAM

NET WT 1 oz (30g)

NDC 49426-099-30

Lidocaine 4% Cream

RECOVERYAFTERCARE.COM

Made in USA

Distributed by Recovery, Inc.

Hanover, MD  21076

©​ Recovery, Inc. 2019

Questions or comments?

[email protected]

RECOVERY

7  49110 22144  7

res


Structured Label Content

Indications and Usage (34067-9)

Uses: Temporarily relieves pain and itching

due to minor cuts, minor scrapes, sunburn,

minor skin irritations, minor burns, insect bites.

Dosage and Administration (34068-7)

Directions: Adults and children 2 years and

older: Apply externally to the affected area up

to 3-4 times daily.

Children under 2 years of age: Consult a

doctor.

Warnings and Precautions (34071-1)

WARNINGS: FOR EXTERNAL USE ONLY.

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

Section 50566-9 (50566-9)

Stop use and ask 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 or increase.

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)

Inactive ingredients: Benzyl Alcohol,

Carbomer 940, Cholesterol, Hydrogenated

Lecithin, Polysorbate 80, Propylene Glycol,

Tocopherol Acetate, Trolamine, Water

Section 55105-1 (55105-1)

Purpose: Topical Anesthetic

Section 55106-9 (55106-9)

Active Ingredients: Lidocaine 4% w/w

Section 60561-8 (60561-8)

Other Information: Store at room

temperature 20°C and 25°C (68°F to

77°F).

Package Label

NUMB

CREAM

NET WT 1 oz (30g)

NDC 49426-099-30

Lidocaine 4% Cream

RECOVERYAFTERCARE.COM

Made in USA

Distributed by Recovery, Inc.

Hanover, MD  21076

©​ Recovery, Inc. 2019

Questions or comments?

[email protected]

RECOVERY

7  49110 22144  7

res


Advanced Ingredient Data


Raw Label Data

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