CALMING ITCH AND IRRITATION- colloidal oatmeal lotion 
Better Planet Brands LLC

----------

Calming Itch & Irritation Lotion

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 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, 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?

Questions? Call toll-free 877.902.2873

Calming Lotion Label

CALMING ITCH AND IRRITATION 
colloidal oatmeal lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:54136-322
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OATMEAL (UNII: 8PI54V663Y) (OATMEAL - UNII:8PI54V663Y) OATMEAL2 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
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)  
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)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:54136-322-81239 g in 1 TUBE; Type 0: Not a Combination Product05/11/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM01605/11/2020
Labeler - Better Planet Brands LLC (960253719)

Revised: 12/2023
Document Id: 0d06c4df-a0ac-6467-e063-6394a90a5538
Set id: a566774a-0ee0-0a7d-e053-2a95a90ac383
Version: 4
Effective Time: 20231221
 
Better Planet Brands LLC