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

Active ingredients Purpose

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

Purpose

Purpose

Skin Protectant

Uses

Uses

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

Warnings

Warnings For external use only.

WHEN USING

When using the product * Do not get into eyes

Stop use and ask a doctor if

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

* Deep or puncture wounds * Animal bites * Serious burns

SAFETY TIP: Keep out of reach of children.

SAFETY TIP: Keep out of reach of children.

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

Directions

Directions

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

Other information

Other information

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

Inactive Ingredients

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

Questions?

Questions? Call toll-free 877.902.2873

PRINCIPAL DISPLAY PANEL

NDC: 54136-322-81. 239 g (236.5 mL) Tube

INGREDIENTS AND APPEARANCE

CALMING ITCH AND IRRITATION 
colloidal oatmeal lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 54136-322
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
SUNFLOWER OIL (UNII: 3W1JG795YI)
WATER (UNII: 059QF0KO0R)
LAVENDER OIL (UNII: ZBP1YXW0H8)
MEADOWFOAM SEED OIL (UNII: 412ZHA4T4Y)
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
SORBITAN OLIVATE (UNII: MDL271E3GR)
COCOA BUTTER (UNII: 512OYT1CRR)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
COCO-GLYCERIDES (UNII: ISE9I7DNUG)
CETEARYL OLIVATE (UNII: 58B69Q84JO)
GLYCERIN (UNII: PDC6A3C0OX)
GLYCERYL STEARATE SE (UNII: FCZ5MH785I)
HIPPOPHAE RHAMNOIDES SEED OIL (UNII: T53SBG6741)
OLIVE OIL (UNII: 6UYK2W1W1E)
SAFFLOWER OIL (UNII: 65UEH262IS)
GLYCERYL LAURATE (UNII: Y98611C087)
SODIUM LEVULINATE (UNII: VK44E1MQU8)
SQUALANE (UNII: GW89575KF9)
TOCOPHEROL (UNII: R0ZB2556P8)
XANTHAN GUM (UNII: TTV12P4NEE)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 54136-322-81	239 g in 1 TUBE; Type 0: Not a Combination Product	05/11/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part347	05/11/2020

Labeler - Better Planet Brands LLC (960253719)