SPL v1
SPL
SPL Set ID dce3c618-85cc-0668-e053-2a95a90af4f7
Route
TOPICAL
Published
Effective Date 2022-04-18
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Petrolatum (35 g) Mineral Oil (55 g)
Inactive Ingredients
Aloe Vera Leaf

Identifiers & Packaging

Marketing Status
UNAPPROVED DRUG OTHER Active Since 2022-04-18

Description

mineral oil, petrolatum


Medication Information

Warnings and Precautions

For external use only

When using this product

■ do not exceed the recommended daily dosage unless directly by a doctor

■ do not put into the rectum by using fingers or any mechanical device or applicator ■ avoid contact with eyes ■ rinse with water to remove ■ do not swallow ■ do not store at temperature above 120 degree F

Indications and Usage

■ spray liverally to the affected area as necessary

Dosage and Administration

for external use only

Description

mineral oil, petrolatum

Section 50565-1

keep out of reach of the children

Section 51727-6

aloe barbadensis leaf extract, matricaria flower extract, sunflower seed oil, glycerin, butlyne glycol

Section 51945-4

Section 55105-1

■ temporarily protects irritated areas ■ temporarily relieves burning ■ temporarily protects inflamed anorectal skin ■ temporarily relieves the symptoms of anorectal skin irritation

Section 55106-9

mineral oil, petrolatum


Structured Label Content

Indications and Usage (34067-9)

■ spray liverally to the affected area as necessary

Dosage and Administration (34068-7)

for external use only

Warnings and Precautions (34071-1)

For external use only

When using this product

■ do not exceed the recommended daily dosage unless directly by a doctor

■ do not put into the rectum by using fingers or any mechanical device or applicator ■ avoid contact with eyes ■ rinse with water to remove ■ do not swallow ■ do not store at temperature above 120 degree F

Section 50565-1 (50565-1)

keep out of reach of the children

Section 51727-6 (51727-6)

aloe barbadensis leaf extract, matricaria flower extract, sunflower seed oil, glycerin, butlyne glycol

Section 51945-4 (51945-4)

Section 55105-1 (55105-1)

■ temporarily protects irritated areas ■ temporarily relieves burning ■ temporarily protects inflamed anorectal skin ■ temporarily relieves the symptoms of anorectal skin irritation

Section 55106-9 (55106-9)

mineral oil, petrolatum


Advanced Ingredient Data


Raw Label Data

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