ECZEMA- colloidal oatmeal lotion
Amyris, 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.

----------

Pipette Eczema Lotion

Active Ingredients

Colloidal Oatmeal 1%

Purpose

Skin Protectant

Uses

Temporarily protects and helps relieve minor skin irritation and itching due to
eczema
rashes

Warnings

For external use only

When using this product

do not get into eyes

Stop use and aks a 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 swallowed, get medical help or contact a Poison Control Center right away.

Directions

Apply as needed

Other information

Protect this product from excessive heat and direct sunlight

Inactive Ingredients

Water, Squalane, Caprylic/Capric Triglyceride, Glycerin, Hydrogenated Sunflower Seed Oil Polyglyceryl-3
Esters, Hydroxystearic/Linolenic/Oleic Polyglycerides, Butyrospermum Parkii (Shea ) Butter, Jojoba Esters.
Cetearyl Alcohol, Hydrogenated Sunflower Seed Oil Glyceryl Esters, Propanediol, Hydroxyacetophenone, Sodium Stearoyl Lactylate, Xanthan
Gum, Citric Acid, Ethylhexylglycerin, Potassium Sorbate, Ceramide NP, Sodium Phytate, Tocopherol.

eczemaUC

ECZEMA
colloidal oatmeal lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:73517-425
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
OATMEAL (UNII: 8PI54V663Y) (OATMEAL - UNII:8PI54V663Y)	OATMEAL	1 g in 100 mL

Ingredient Name	Strength
Inactive Ingredients
WATER (UNII: 059QF0KO0R)
SQUALANE (UNII: GW89575KF9)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
GLYCERIN (UNII: PDC6A3C0OX)
SUNFLOWER SEED OIL GLYCERETH-8 ESTERS (UNII: 358X17CAT0)
12-HYDROXYSTEARIC ACID (UNII: 933ANU3H2S)
SHEA BUTTER (UNII: K49155WL9Y)
HYDROGENATED JOJOBA OIL, RANDOMIZED (UNII: Q47ST02F58)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
PROPANEDIOL (UNII: 5965N8W85T)
HYDROXYACETOPHENONE (UNII: G1L3HT4CMH)
SODIUM STEAROYL LACTYLATE (UNII: IN99IT31LN)
XANTHAN GUM (UNII: TTV12P4NEE)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
CERAMIDE NP (UNII: 4370DF050B)
HEXASODIUM PHYTATE (UNII: ZBX50UG81V)
TOCOPHEROL (UNII: R0ZB2556P8)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:73517-425-01	1 in 1 CARTON	02/01/2021
1		177 mL in 1 TUBE; Type 0: Not a Combination Product
2	NDC:73517-425-02	30 mL in 1 TUBE; Type 0: Not a Combination Product	02/01/2021

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	M016	02/01/2021

Labeler - Amyris, Inc (185930182)