Active ingredient

Colloidal oatmeal 2%

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

avoid contact with eyes

Stop use and ask a doctor if

condition worsens
symptoms persist for 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 immediately.

Directions

apply to affected areas of skin as needed

Inactive ingredients

water, glycerin, dimethicone, petrolatum, propanediol, hydroxyethyl acrylate/sodium acryloyldimethyl taurate copolymer, jojoba esters, cetyl alcohol, aloe barbadensis leaf juice, glyceryl stearate, butyrospermum parkii (shea) butter extract, isohexadecane, avena sativa (oat) kernel extract, bisabolol, zingiber officinale (ginger) root extract, C10-30 cholesterol/lanosterol esters, ceramide NG, hydrolyzed jojoba esters, tocopheryl acetate, magnesium ascorbyl phosphate, panthenol, ethylhexylglycerin, C12-15 alkyl benzoate, tribehenin, potassium hydroxide, EDTA, phenoxyethanol, PEG-10 phytosterol, methylparaben, polysorbate 60, palmitoyl hexapeptide-12

PRINCIPAL DISPLAY PANEL

Gold Bond Eczema Relief Medicated Skin Protectant Cream
Net wt 8 oz (226 g)

PRINCIPAL DISPLAY PANEL
Gold Bond Eczema Relief Medicated Skin Protectant Cream
Net wt 8 oz (226 g)

GOLD BOND ECZEMA RELIEF MEDICATED SKIN PROTECTANT CREAM
colloidal oatmeal cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:41167-0669
Route of Administration	TOPICAL

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

Ingredient Name	Strength
Inactive Ingredients
WATER (UNII: 059QF0KO0R)
GLYCERIN (UNII: PDC6A3C0OX)
DIMETHICONE (UNII: 92RU3N3Y1O)
PETROLATUM (UNII: 4T6H12BN9U)
PROPANEDIOL (UNII: 5965N8W85T)
HYDROXYETHYL ACRYLATE/SODIUM ACRYLOYLDIMETHYL TAURATE COPOLYMER (100000 MPA.S AT 1.5%) (UNII: 86FQE96TZ4)
JOJOBA OIL, RANDOMIZED (UNII: 7F0EV20QYL)
CETYL ALCOHOL (UNII: 936JST6JCN)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
GLYCERYL STEARATE (UNII: 230OU9XXE4)
BUTYROSPERMUM PARKII (SHEA) BUTTER (UNII: K49155WL9Y)
ISOHEXADECANE (UNII: 918X1OUF1E)
OAT (UNII: Z6J799EAJK)
LEVOMENOL (UNII: 24WE03BX2T)
GINGER (UNII: C5529G5JPQ)
C10-30 CHOLESTEROL/LANOSTEROL ESTERS (UNII: 137SL7IL0Y)
CERAMIDE NG (UNII: C04977SRJ5)
HYDROLYZED JOJOBA ESTERS (ACID FORM) (UNII: UDR641JW8W)
ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
MAGNESIUM ASCORBYL PHOSPHATE (UNII: 0R822556M5)
PANTHENOL (UNII: WV9CM0O67Z)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)
TRIBEHENIN (UNII: 8OC9U7TQZ0)
POTASSIUM HYDROXIDE (UNII: WZH3C48M4T)
EDETIC ACID (UNII: 9G34HU7RV0)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
METHYLPARABEN (UNII: A2I8C7HI9T)
POLYSORBATE 60 (UNII: CAL22UVI4M)
PALMITOYL HEXAPEPTIDE-12 (UNII: HO4ZT5S86C)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:41167-0669-2	226 g in 1 TUBE; Type 0: Not a Combination Product	04/01/2022
2	NDC:41167-0669-1	121 g in 1 TUBE; Type 0: Not a Combination Product	02/01/2023
3	NDC:41167-0669-3	396 g in 1 TUBE; Type 0: Not a Combination Product	04/01/2022

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC Monograph Drug	M016	04/01/2022

Labeler - Chattem, Inc. (003336013)