Gold Bond Medicated Eczema Relief: Package Insert and Label Information

GOLD BOND MEDICATED ECZEMA RELIEF- oatmeal cream
Chattem, 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.

Drug Facts

Active i ngredient

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 produc t

• 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, cetyl alcohol, jojoba esters, aloe barbadensis leaf juice, butyrospermum parkii (shea) butter extract, glyceryl stearate, isohexadecane, avena sativa (oat) kernel extract, palmitoyl hexapeptide-12, bisabolol, ceramide NG, zingiber officinale (ginger) root extract, hydrolyzed jojoba esters, tocopheryl acetate, magnesium ascorbyl phosphate, PEG-10 phytosterol, panthenol, ethylhexylglycerin, C12-15 alkyl benzoate, tribehenin, disodium EDTA, hydroxyacetophenone, 1,2-hexanediol, caprylyl glycol, polysorbate 60

PRINCIPAL DISPLAY PANEL

7 moisturizers & 3 vitamins
GOLD BOND_®
2 % colloidal oatmeal
ECZEMA RELIEF
Skin Protectant Cream
Net wt 5.5 oz (155 g)

GOLD BOND MEDICATED ECZEMA RELIEF colloidal oatmeal cream

Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:41167-0567 Route of Administration TOPICAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OATMEAL (OATMEAL) OATMEAL 20 mg in 1 g

Inactive Ingredients Ingredient Name Strength WATER GLYCERIN DIMETHICONE PETROLATUM PROPANEDIOL HYDROXYETHYL ACRYLATE/SODIUM ACRYLOYLDIMETHYL TAURATE COPOLYMER (45000 MPA.S AT 1%) CETYL ALCOHOL ALOE VERA LEAF SHEA BUTTER GLYCERYL MONOSTEARATE ISOHEXADECANE OAT PALMITOYL HEXAPEPTIDE-12 LEVOMENOL CERAMIDE NG GINGER HYDROLYZED JOJOBA ESTERS (ACID FORM) ALPHA-TOCOPHEROL ACETATE MAGNESIUM ASCORBYL PHOSPHATE PANTHENOL ETHYLHEXYLGLYCERIN ALKYL (C12-15) BENZOATE TRIBEHENIN EDETATE DISODIUM ANHYDROUS HYDROXYACETOPHENONE 1,2-HEXANEDIOL CAPRYLYL GLYCOL POLYSORBATE 60

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:41167-0567-1 155 g in 1 TUBE None

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part347 12/22/2014

Labeler — Chattem, Inc. (003336013)

Revised: 12/2022 Chattem, Inc.