Recovery Numbing Spray

Recovery Numbing Spray
SPL v2
SPL
SPL Set ID e4e05cae-56a6-b2b3-e053-2a95a90a104b
Route
TOPICAL
Published
Effective Date 2022-08-01
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Inactive Ingredients
Benzyl Alcohol Alcohol Glycerin Aloe Vera Leaf Water Edetate Disodium Anhydrous

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2022-08-01

Description

Active Ingredients Lidocaine HCl 5 %


Medication Information

Warnings and Precautions

WARNINGS: FOR EXTERNAL USE ONLY

Indications and Usage

USES: Temporarily relieves pain, itching and burning associated with inflamed hemorrhoidal tissues.

Description

Active Ingredients Lidocaine HCl 5 %

Section 50565-1

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away. If pregnant or breast-feeding, ask a health professional before use.

Section 50566-9

Stop and ask a doctor if an allergic reaction or rectal bleeding occurs; redness, irritation, swelling, pain or other symptoms begin or increase; condition worsens or does not improve within 7 days.

Section 50567-7

When using this product avoid contact with eyes

Rinse with water to remove

Do not use in large quantities particularl over raw skin or blistered areas

Section 51727-6

Inactive Ingredients: Aloe Barbadensis Leaf Powder, Benzyl Alcohol, Deionized Water, Disodium EDTA, Ethyl Alcohol SD 40B, Glycerin

Section 51945-4

PRODUCT LABEL

Section 53414-9

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

Section 55105-1

Purpose

Topical Anesthetic

Section 55106-9

Active Ingredients

Lidocaine HCl 5 %

Section 60561-8

Other information: Store between 14C - 25C (58F - 77F). Avoid freezing, excessive heat or direct sunlight.

Section 69718-5

RECOVERY

NUMBING SPRAY

FAST-ACTING TOPICAL

ANESTHETIC WITH ALOE

NET WT 4 FL OZ (118 mL)

NDC 76348-585-04

Directions:

Adults and children 12 years and older: When practical, clean area with mild soap and warm water and rinse thoroughly. Gently pat or blot dry with a clean tissue or soft cloth before applying. Apply to the affected area up to 6 times a day.

Children under 12 years of age: Consult a doctor.


Structured Label Content

Indications and Usage (34067-9)

USES: Temporarily relieves pain, itching and burning associated with inflamed hemorrhoidal tissues.

Warnings and Precautions (34071-1)

WARNINGS: 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. If pregnant or breast-feeding, ask a health professional before use.

Section 50566-9 (50566-9)

Stop and ask a doctor if an allergic reaction or rectal bleeding occurs; redness, irritation, swelling, pain or other symptoms begin or increase; condition worsens or does not improve within 7 days.

Section 50567-7 (50567-7)

When using this product avoid contact with eyes

Rinse with water to remove

Do not use in large quantities particularl over raw skin or blistered areas

Section 51727-6 (51727-6)

Inactive Ingredients: Aloe Barbadensis Leaf Powder, Benzyl Alcohol, Deionized Water, Disodium EDTA, Ethyl Alcohol SD 40B, Glycerin

Section 51945-4 (51945-4)

PRODUCT LABEL

Section 53414-9 (53414-9)

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

Section 55105-1 (55105-1)

Purpose

Topical Anesthetic

Section 55106-9 (55106-9)

Active Ingredients

Lidocaine HCl 5 %

Section 60561-8 (60561-8)

Other information: Store between 14C - 25C (58F - 77F). Avoid freezing, excessive heat or direct sunlight.

Section 69718-5 (69718-5)

RECOVERY

NUMBING SPRAY

FAST-ACTING TOPICAL

ANESTHETIC WITH ALOE

NET WT 4 FL OZ (118 mL)

NDC 76348-585-04

Directions: (DIRECTIONS:)

Adults and children 12 years and older: When practical, clean area with mild soap and warm water and rinse thoroughly. Gently pat or blot dry with a clean tissue or soft cloth before applying. Apply to the affected area up to 6 times a day.

Children under 12 years of age: Consult a doctor.


Advanced Ingredient Data


Raw Label Data

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