Bath Bomb (allantoin & Sodium Bicarbonate)

Bath Bomb (allantoin & Sodium Bicarbonate)
SPL v1
SPL
SPL Set ID 08c7c313-cf36-fb46-e063-6294a90a7304
Route
TOPICAL
Published
Effective Date 2025-08-06
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Allantoin (1.9 g) Bicarbonate Ion (18.7 g)
Inactive Ingredients
Polysorbate 80 Starch, Corn Anhydrous Citric Acid Mica Jojoba Oil Cannabidiol Rose Oil Magnesium Sulfate Anhydrous Lavender Oil Orange Oil Lemon Oil Eucalyptus Oil Peppermint Oil

Identifiers & Packaging

Pill Appearance
Shape: round Color: pink Color: purple Color: orange Color: yellow Color: white Color: black Size: 55 mm
Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-08-06

Description

Allantoin 0.5% Sodium Bicarbonate 40%

Purpose

Skin Protectant Skin Protectant


Medication Information

Purpose

Skin Protectant

Skin Protectant

Description

Allantoin 0.5% Sodium Bicarbonate 40%

Uses

Temporarily protects minor cuts, burns, scrapes, chafed, chapped, or cracked skin.

Section 51945-4

Warnings

For external use only.

Directions

Adults and children 2 years and over. For use as soak in bath, dissolve 1 bath bomb in warm tub of water, Soak for 10 to 30 minutes as needed, or as directed by doctor. Pat dry (do not rub) to leave a thin layer on the skin

Back Label

Front Label

Do Not Use On

Deep or puncture wounds, animal bites, serious burns.

Other Information

store at 20-25C (68-77 F)

Active Ingredients

Allantoin 0.5%

Sodium Bicarbonate 40%

In Case of Overdose

seek medical help or contact a poison control center right away.

Inactive Ingredients

Cannabidiol (CBD) Isolate, Citric acid, Corn Starch, essential oils, Jojoba oil, Magnesium Sulfate (Epsom salts), Mica powder, polysorbate 80.

When Using This Product

Do not get into eyes

Stop Use and Ask A Doctor If

The condition worsens, symptoms last more than 7 days or clear up and occur again within a few days

Keep Out of Reach of Children

Keep out of reach of children

If Pregnant Or Breast Feeding

consult a health professional before use.


Structured Label Content

Uses (uses)

Temporarily protects minor cuts, burns, scrapes, chafed, chapped, or cracked skin.

Section 51945-4 (51945-4)

Purpose

Skin Protectant

Skin Protectant

Warnings

For external use only.

Directions

Adults and children 2 years and over. For use as soak in bath, dissolve 1 bath bomb in warm tub of water, Soak for 10 to 30 minutes as needed, or as directed by doctor. Pat dry (do not rub) to leave a thin layer on the skin

Back Label (back label)

Front Label (front label)

Do Not Use On (Do not use on)

Deep or puncture wounds, animal bites, serious burns.

Other Information (other information)

store at 20-25C (68-77 F)

Active Ingredients

Allantoin 0.5%

Sodium Bicarbonate 40%

In Case of Overdose (in case of overdose)

seek medical help or contact a poison control center right away.

Inactive Ingredients (Inactive ingredients)

Cannabidiol (CBD) Isolate, Citric acid, Corn Starch, essential oils, Jojoba oil, Magnesium Sulfate (Epsom salts), Mica powder, polysorbate 80.

When Using This Product (When using this product)

Do not get into eyes

Stop Use and Ask A Doctor If (Stop use and ask a doctor if)

The condition worsens, symptoms last more than 7 days or clear up and occur again within a few days

Keep Out of Reach of Children (Keep out of reach of children)

Keep out of reach of children

If Pregnant Or Breast Feeding (if pregnant or breast feeding)

consult a health professional before use.


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)