MedPath

Upside Down Pain Relief

Approved
Approval ID

31c2cd25-1fec-5ec5-e063-6394a90a24b4

Product Type

HUMAN OTC DRUG LABEL

Effective Date

Aug 15, 2025

Manufacturers
FDA

Fridababy, LLC

DUNS: 783729598

Products 1

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

Benzocaine, Glycerin

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code72705-300
Application NumberM015
Product Classification
M
Marketing Category
C200263
G
Generic Name
Benzocaine, Glycerin
Product Specifications
Route of AdministrationTOPICAL
Effective DateAugust 15, 2025
FDA Product Classification

INGREDIENTS (11)

GLYCERINActive
Quantity: 20 mg in 1 g
Code: PDC6A3C0OX
Classification: ACTIB
BENZOCAINEActive
Quantity: 20 mg in 1 g
Code: U3RSY48JW5
Classification: ACTIB
HAMAMELIS VIRGINIANA ROOT BARK/STEM BARKInactive
Code: T7S323PKJS
Classification: IACT
POTASSIUM SORBATEInactive
Code: 1VPU26JZZ4
Classification: IACT
ALOE BARBADENSIS LEAF JUICEInactive
Code: RUE8E6T4NB
Classification: IACT
CITRIC ACIDInactive
Code: 2968PHW8QP
Classification: IACT
SODIUM BENZOATEInactive
Code: OJ245FE5EU
Classification: IACT
ALCOHOL 95%Inactive
Code: 7528N5H79B
Classification: IACT
DIMETHYL ETHERInactive
Code: AM13FS69BX
Classification: IACT
POLYETHYLENE GLYCOL 300Inactive
Code: 5655G9Y8AQ
Classification: IACT
PPG-3 METHYL ETHERInactive
Code: 1827NY57O3
Classification: IACT

Drug Labeling Information

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LOINC: 51945-4Updated: 8/15/2025

Upside Sown Pain Relief Spray

3.5 oz Upside Down Pain Relief Spray 3.5 oz

INDICATIONS & USAGE SECTION

LOINC: 34067-9Updated: 8/31/2025

Uses

■ Helps relieve discomfort

in the perianal area. ■ Temporarily protects

inflamed perianal skin.

DOSAGE & ADMINISTRATION SECTION

LOINC: 34068-7Updated: 8/31/2025

Directions

Adults: •When practical, cleanse the affected area with mild soap and warm water, and rinse thoroughly. •Gently pat dry before use. •Hold the can upside- down and point spray nozzle 6 to 12 inches from affected area. •Apply externally up to 6 times daily or after each bowel movement.

Children under 12 years of age: consult a doctor.

WARNINGS SECTION

LOINC: 34071-1Updated: 8/31/2025

Warnings

For extemal use only

FLAMMABLE. Do not use near heat,

flame, or fire or wlile smoking.

When using this product ■ Use only as
directed. ■ Do not exceed recommended
daily dosage unless directed by a doctor.
■ Intentional misuse by deliberately
concentrating or inhaling the contents
can be hmmful or fatal. ■ Do not put this
product into the rectum by using fingers
or any mechanical device or applicator.

Stop use and ask a doctor if
■ Condition worsens or does not improve
within 7 days. ■ Bleeding occurs

■ Certain persons can develop allergic

reactions to ingredients in this product. If the

symptoms being treated does not subside or if

redness, irritation, swelling, pain, or other

syptoms develop or increase, discontinue

use and consult a doctor. ■ Avoid spaying in

eyes. ■ Contents under pressure. Do not

puncture or incinerate. ■ Do not store at

temperature above 120ºF. Keep out of reach

of children. ■ If swallowed, get medical help

or contact a Poison Control Cerier right away.

Keep out of reach of children. •If swallowed, get medical help or contact a Poison Control Center right away.

INACTIVE INGREDIENT SECTION

LOINC: 51727-6Updated: 8/31/2025

Inactive Ingredients

aloe barbadensis leaf juice, citric acid, dimethyl ether, dipropylene glycol, ethanol, polyethylene glycol, potassium sorbate, PPG-3 methyl ether, sodium benzoate, witch hazel extract

OTC - PURPOSE SECTION

LOINC: 55105-1Updated: 8/31/2025

Purpose

Local anesthetic

Protectant

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Upside Down Pain Relief - FDA Drug Approval Details