CALMING ITCH AND IRRITATION- colloidal oatmeal lotion

Calming Itch and Irritation by

Drug Labeling and Warnings

Calming Itch and Irritation by is a Otc medication manufactured, distributed, or labeled by Better Planet Brands LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredients

Colloidal Oatmeal 2.0%

Purpose

Skin Protectant

Uses

temporarily protects and helps relieve minor skin irritation and itching due to: rashes

eczema

poison ivy, oak, or sumac

insect bites

Warnings

For external use

When using this product

Do not get into eyes

Stop use and ask doctor if

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

Keep out of reach of children.

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

Directions

Apply as needed.

Other information

Remove quality seal.

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

Inactive ingredients

WATER, ALOE BARBADENSIS LEAF JUICE POWDER*, CETEARYL OLIVATE, CARTHAMUS TINCTORIUS (SAFFLOWER) SEED OIL, THEOBROMA CACAO (COCOA) SEED BUTTER*, LIMNANTHES ALBA (MEADOWFOAM) SEED OIL, SORBITAN OLIVATE, GLYCERIN, COCOGLYCERIDES, GLYCERYL STEARATE SE, TOCOPHEROL, HIPPOPHAE RHAMNOIDES FRUIT OIL*, BUTYROSPERMUM PARKII (SHEA) BUTTER, OLEA EUROPABA (OLIVE) FRUIT OIL, HELIANTHUS ANNUUS (SUNFLOWER) SEED OIL, SALVIA HISPANICA SEED OIL, CHENOPODIUM QUINOA SEED OIL, XANTHAN GUM, SQUALANE, SODIUM LEVULINATE, GLYCERYL LAURATE, POTASSIUM SORBATE, CITRIC ACID.

Questions?

Call toll-free 877.902.2873

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

CALMING ITCH AND IRRITATION 
colloidal oatmeal lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 54136-183
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OATMEAL (UNII: 8PI54V663Y) (OATMEAL - UNII:8PI54V663Y)	OATMEAL	2 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
OLIVE OIL (UNII: 6UYK2W1W1E)
SUNFLOWER OIL (UNII: 3W1JG795YI)
WATER (UNII: 059QF0KO0R)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
HIPPOPHAE RHAMNOIDES SEED OIL (UNII: T53SBG6741)
SQUALANE (UNII: GW89575KF9)
TOCOPHEROL (UNII: R0ZB2556P8)
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)
SORBITAN OLIVATE (UNII: MDL271E3GR)
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
CHIA SEED OIL (UNII: MC2LH51BO7)
MEADOWFOAM SEED OIL (UNII: 412ZHA4T4Y)
SHEA BUTTER (UNII: K49155WL9Y)
CETEARYL OLIVATE (UNII: 58B69Q84JO)
COCO-GLYCERIDES (UNII: ISE9I7DNUG)
SODIUM LEVULINATE (UNII: VK44E1MQU8)
COCOA BUTTER (UNII: 512OYT1CRR)
XANTHAN GUM (UNII: TTV12P4NEE)
GLYCERYL LAURATE (UNII: Y98611C087)
SAFFLOWER OIL (UNII: 65UEH262IS)
GLYCERYL STEARATE SE (UNII: FCZ5MH785I)
GLYCERIN (UNII: PDC6A3C0OX)
QUINOA OIL (UNII: M437LS0K52)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 54136-183-24	239 g in 1 TUBE; Type 0: Not a Combination Product	07/31/2024

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M016	07/31/2024

Labeler - Better Planet Brands LLC (960253719)