Eczema Relief Cream: Package Insert and Label Information

ECZEMA RELIEF CREAM- oatmeal cream
HEMPFUSION, INC.

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Active ingredient

Colloidal Oatmeal 1%

Purpose

Colloidal Oatmeal 1%…Skin Protectant

Uses

Temporarily protects and helps relieve minor skin irritation and itching due to:

• eczema
• poison ivy, oak or sumac
• insect bites

Warnings

For external use only

When using this product

• do not get into eyes

Stop use and ask doctor if

• condition worsens
• symptoms persist for more than 7 days or clear up and occur again within a few days

If pregnant or breastfeeding, ask a health professional before use.

Keep out of reacho f children. If swallowed, get medical help or contact a Poison Control Center right away.

Directions

Apply as needed.

Other information

• Store in a cool dry place away from light

Inactive ingredients

water (aqua), coco-caprylate, organic shea (butyrospermum parkii) butter, organic jojoba (simmondsia chinensis) seed oil, glycerin, methylsulfonylmethane (MSM), cetearyl alcohol, cetearyl olivate, organic hemp (cannabis sativa) aerial part extract, organic hemp (cannabis sativa) seed oil, sorbitan olivate, organic aloe (aloe barbadensis) leaf juice, cetearyl glucoside, ethylhexylglycerin, glucose,

allantoin, xanthan gum, linalool, limonene, lactoperoxidase, glucose oxidase, organic lavender (lavandula angustifolia) oil, black pepper (piper nigrum) fruit oil, clove (syzygium aromaticum) flower oil, organic geranium (pelargonium graveolens) flower oi

Questions or comments?

Call 877-669-4367 Monday through Friday, 9am-5pm EST.

Principal Display Panel

HempFusion

Eczema

Relief

CREAM

Colloidal Oatmeal 1%

Including nourishing Aloe Vera , hemp extract with naturally occuring CBD (100mg/bottle) + Terpenes (60mg/bottle) from black pepper and clove & other natural skin moisturizers

U.S. Hemp Authority H Certified

NON-GMO

ALL SKIN TYPES

50mL (1.69 fl oz)

ECZEMA RELIEF CREAM colloidal oatmeal 1% cream

Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:73672-983 Route of Administration TOPICAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OATMEAL (OATMEAL) OATMEAL 10 mg in 1 mL

Inactive Ingredients Ingredient Name Strength LIMONENE, (+)- ALOE ETHYLHEXYLGLYCERIN ALLANTOIN LINALOOL, (+/-)- MYELOPEROXIDASE GLUCOSE OXIDASE LAVENDER OIL CETOSTEARYL ALCOHOL SORBITAN OLIVATE SHEA BUTTER GLYCERIN WATER COCO-CAPRYLATE JOJOBA OIL DIMETHYL SULFONE CETEARYL OLIVATE HEMP CANNABIS SATIVA SEED OIL CETEARYL GLUCOSIDE ANHYDROUS DEXTROSE XANTHAN GUM BLACK PEPPER OIL CLOVE OIL PELARGONIUM GRAVEOLENS FLOWER OIL

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:73672-983-50 1 TUBE in 1 CARTON contains a TUBE 1 50 mL in 1 TUBE This package is contained within the CARTON (73672-983-50)

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part347 02/10/2020

Labeler — HEMPFUSION, INC. (117152485)

Establishment
Name	Address	ID/FEI	Operations
Universal Packaging Systems, Inc. (DBA Paklab)		177711082	manufacture (73672-983)

Revised: 03/2021 HEMPFUSION, INC.