Acutens - Burn Relief Aloe Gel (80551-001)

Acutens - Burn Relief Aloe Gel (80551-001)
SPL v7
SPL
SPL Set ID 48c435fe-2670-4b80-bf01-923dc9354422
Route
TOPICAL
Published
Effective Date 2021-03-24
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Inactive Ingredients
Aloe Oat Caprylyl Glycol Chlorphenesin Dimethyl Isosorbide Glycerin Cetyl Hydroxyethylcellulose (350000 Mw) Isopropyl Alcohol Phenoxyethanol Polysorbate 20 Propanediol .alpha.-tocopherol Acetate Water

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2021-03-18

Description

LIDOCAINE HYDROCHLORIDE               Pain Reliever

Purpose

LIDOCAINE HYDROCHLORIDE               Pain Reliever


Medication Information

Purpose

LIDOCAINE HYDROCHLORIDE               Pain Reliever

Description

LIDOCAINE HYDROCHLORIDE               Pain Reliever

Uses:

For temporary relief of pain and itching due to • sunburn • minor burns • insect bites • minor cuts • scrapes • minor skin irritation

Section 51945-4

Warnings

When using this product• Avoid contact with eyes. Rinse with water if contact occurs.

Stop use and ask doctor if• symptoms persist for more than 7 days or clear up and occur again within a few days.

Do not usein large quantities, particularly over raw surfaces or blistered area

Direction

adults and children over 2 years and older: • Apply to affected area not more than 3-4 times a day

• Children under 2 years old: consult a doctor

Inactive Ingredients

Aloe Barbadensis Leaf Extract

Avena Sativa (Oat) Kernel Extract

Blue 1

Caprylyl Glycol

Chlorphenesin

Dimethyl Isosorbide

Glycerin

Hydroxyethylcellulose

Isopropyl Alcohol

Phenoxyethanol

Polysorbate 20

Propanediol

Tocopheryl Acetate

Water

Active Ingredients                                         purpose

LIDOCAINE HYDROCHLORIDE               Pain Reliever


Structured Label Content

Uses:

For temporary relief of pain and itching due to • sunburn • minor burns • insect bites • minor cuts • scrapes • minor skin irritation

Section 51945-4 (51945-4)

Warnings

When using this product• Avoid contact with eyes. Rinse with water if contact occurs.

Stop use and ask doctor if• symptoms persist for more than 7 days or clear up and occur again within a few days.

Do not usein large quantities, particularly over raw surfaces or blistered area

Direction

adults and children over 2 years and older: • Apply to affected area not more than 3-4 times a day

• Children under 2 years old: consult a doctor

Inactive Ingredients (Inactive ingredients)

Aloe Barbadensis Leaf Extract

Avena Sativa (Oat) Kernel Extract

Blue 1

Caprylyl Glycol

Chlorphenesin

Dimethyl Isosorbide

Glycerin

Hydroxyethylcellulose

Isopropyl Alcohol

Phenoxyethanol

Polysorbate 20

Propanediol

Tocopheryl Acetate

Water

Active Ingredients                                         purpose (Active ingredients                                         Purpose)

LIDOCAINE HYDROCHLORIDE               Pain Reliever


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)