Dch Numbing Relief Spray, Lidocaine 5%

Dch Numbing Relief Spray, Lidocaine 5%
SPL v2
SPL
SPL Set ID ffd70a31-7d0c-d2d0-e053-6394a90a8674
Route
TOPICAL
Published
Effective Date 2023-06-08
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Lidocaine (5 g)
Inactive Ingredients
Alpha-tocopherol Acetate Carbomer 940 Trolamine Glycerin Propylene Glycol Alcohol Chamomile Cucumber Disodium Cocoamphodipropionate Water Edetate Disodium Aloe Vera Leaf

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2023-01-30

Description

Lidocaine 5%


Medication Information

Warnings and Precautions

For external use only. Flammable--Keep away from fire or flame.

When using this product avoid contact with eyes, do not exceed recommended dosage unless directed by a doctor, do not put this product into the rectum by using fingers or any mechanical device or applicator, contents under pressure. Do not puncture or incinerate. Do not store at temperatures above 120F.

Stop use and ask a doctor if rectal bleeding occurs, condition worsens or does not improve within 7 days, allergic reaction occurs to ingredients in this product, symptom being treated does not subside or if redness, irritation, swelling, pain or other symptoms develop or increase. i

Indications and Usage

For the local itching and pain associated with anorectal disorders or inflammation.

Dosage and Administration

When practical, cleanse the affected area with mild soap and warm water, Rinse thoroughly and gently pat dry. Spray affected area. Wash hands after applying. Adults and children 2 years of age and older, apply externally to the affected area up to 6 times a day. Children under 12 years of age: consult a doctor.

Description

Lidocaine 5%

Section 50565-1

If swallowed, get medical help or contact a Poison Control Center right away.

Section 51727-6

Water, alcohol denat., propylene glycol, glycerin, aloe barbadensis leaf extract, tocopheryl acetate, chamomilla recutita (matricaria) flower extract, cucumis sativus (cucumber) fruit extract, disodium cocoamphodipropionate, carbomer, disodium EDTA, triethanolamine.

Section 51945-4

Section 55105-1



Topical anesthetic

Section 55106-9

Lidocaine 5%


Structured Label Content

Indications and Usage (34067-9)

For the local itching and pain associated with anorectal disorders or inflammation.

Dosage and Administration (34068-7)

When practical, cleanse the affected area with mild soap and warm water, Rinse thoroughly and gently pat dry. Spray affected area. Wash hands after applying. Adults and children 2 years of age and older, apply externally to the affected area up to 6 times a day. Children under 12 years of age: consult a doctor.

Warnings and Precautions (34071-1)

For external use only. Flammable--Keep away from fire or flame.

When using this product avoid contact with eyes, do not exceed recommended dosage unless directed by a doctor, do not put this product into the rectum by using fingers or any mechanical device or applicator, contents under pressure. Do not puncture or incinerate. Do not store at temperatures above 120F.

Stop use and ask a doctor if rectal bleeding occurs, condition worsens or does not improve within 7 days, allergic reaction occurs to ingredients in this product, symptom being treated does not subside or if redness, irritation, swelling, pain or other symptoms develop or increase. i

Section 50565-1 (50565-1)

If swallowed, get medical help or contact a Poison Control Center right away.

Section 51727-6 (51727-6)

Water, alcohol denat., propylene glycol, glycerin, aloe barbadensis leaf extract, tocopheryl acetate, chamomilla recutita (matricaria) flower extract, cucumis sativus (cucumber) fruit extract, disodium cocoamphodipropionate, carbomer, disodium EDTA, triethanolamine.

Section 51945-4 (51945-4)

Section 55105-1 (55105-1)



Topical anesthetic

Section 55106-9 (55106-9)

Lidocaine 5%


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)