Calming Itch & Irritation Lotion

Manufacturer
Better Planet Brands LLC
Effective date
2025-12-03
Label type
HUMAN OTC DRUG LABEL
Version
6
Source
monthly-update
Hydrated at
2026-06-03 17:45:14

Label at a glance#

ProductCalming Itch and Irritation
Active ingredientOATMEAL
Label structure13 sections

Indications and uses

Uses * Help prevent and temporarily protects chafed, chapped or cracked skin

Dosage and administration

Directions * Apply liberally or as needed. Do not use if quality seal is broken

Label contents#

Full prescribing information#

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Active ingredients Purpose

Colloidal Oatmeal 2.0%........... Skin Protectant

Purpose

OTC - PURPOSE SECTION

Purpose

Skin Protectant

Uses

INDICATIONS & USAGE SECTION

Uses

* Help prevent and temporarily protects chafed, chapped or cracked skin

Warnings

WARNINGS SECTION

WarningsFor external use only.

OTC - WHEN USING SECTION

When using the product* Do not get into eyes

Stop use and ask a doctor if

OTC - STOP USE SECTION

Stop use and ask a doctor if

* Condition worsens * Symptoms last more than 7 days or clear up and occur again within a few days

Do not use on

OTC - DO NOT USE SECTION

* Deep or puncture wounds * Animal bites * Serious burns

SAFETY TIP: Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

SAFETY TIP: Keep out of reach of children.

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

Directions

DOSAGE & ADMINISTRATION SECTION

Directions

* Apply liberally or as needed. Do not use if quality seal is broken

Other information

OTHER SAFETY INFORMATION

Other information

* Remove quality seal. Do not use if quality seal is broken. Store at room temperature.

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Inactive Ingredients ALOE BARBADENSIS LEAF JUICE*; CARTHAMUS TINCTORIUS (SAFFLOWER) SEED OIL, WATER, COCOGLYCERIDES, GLYCERYL STEARATE SE, THEOBROMA CACAO (COCOA) SEED BUTTER, LIMNANTHES ALBA (MEADOWFOAM) SEED OIL GLYCERIN, CETEARYL OLIVATE, HELIANTHUS ANNUUS (SUNFLOWER) SEED OIL, SORBITAN OLIVATE, OLEA EUROPAEA (OLIVE) FRUIT OIL, GLYCERYL LAURATE, TOCOPHEROL, LAVANDULA ANGUSTIFOLIA
(LAVENDER) OIL, HIPPOPHAE RHAMNOIDES SEED OIL, XANTHAN GUM, SQUALANE, SODIUM LEVULINATE, POTASSIUM SORBATE.

Questions?

OTC - QUESTIONS SECTION

Questions? Call toll-free 877.902.2873

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Calming Lotion LabelCalming Lotion Label

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
ebc62596-fc97-4d03-9483-7ba095d25db7Product name120151210

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 23 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
54136-32254136-322-81

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 21 matching rows.

Source Document#

Source XML · Source PDF

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
45134ee4-901b-b621-e063-6394a90abbf8a566774a-0ee0-0a7d-e053-2a95a90ac3832025-12-03WarningsExact identifier
spl id: 45134ee4-901b-b621-e063-6394a90abbf8
spl set id: a566774a-0ee0-0a7d-e053-2a95a90ac383

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.