SIGNATURE CARE HYDROCORTISONE- hydrocortisone lotion 
Safeway

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.

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Better Living Brands LLC Hydrocortisone 1% Drug Facts

Active ingredient

Hydrocortisone 1%

Purpose

Anti-itch

Uses

temporarily relieves itching associated with minor skin irritations, rashes, and inflammation due to eczema
other uses of this product should be only under the advice and supervision of a doctor

Warnings

For external use only

Do not use

for the treatment of diaper rash. Consult a doctor.

When using this product

avoid contact with eyes
do not use more than directed unless told to do so by a doctor

Stop use and ask a doctor if

condition worsens, or if symptoms persist for more than 7 days or clear up and occur again within a few days, and do not begin use of any other hydrocortisone product unless you have asked a doctor

Keep out of reach of children.

If swallowed, get medical help or contact a Poison Control Center right away. (1-800-222-1222)

Directions

adults and children 2 years of age and older: apply to affected area not more than 3 to 4 times daily
children under 2 years of age: ask a doctor

Other information

store at 20-25°C (68-77°F)
contents filled by weight, not volume

Inactive ingredients

aloe barbadensis leaf juice, avena sativa (oat) kernel extract, bisabolol, boswellia serrata gum, butyrospermum parkii (shea butter) extract, cetyl alcohol, dextrin, dimethicone, dipropylene glycol, edetate disodium, glycerin, glyceryl stearate, hydroxyethyl acrylate/sodium acryloyldimethyl taurate copolymer, isohexadecane, magnesium ascorbyl phosphate, maltodextrin, methyl gluceth-20, methylparaben, petrolatum, phenoxyethanol, polysorbate 60, propylparaben, purified water, retinyl palmitate, sodium citrate, tocopheryl acetate, zingiber officinale (ginger) root extract

Questions or comments?

1-888-723-3929

Package/Label Principal Display Panel

Compare To Cortizone●10® Intensive Healing Lotion active ingredient

Quality Guaranteed

#1 DOCTOR RECOMMENDED ITCH RELIEF ACTIVE INGREDIENT

Hydrocortisone 1%

Anti-Itch Lotion

ECZEMA AND ITCHY, DRY SKIN

MAXIMUM STRENGTH

Fast, lasting itch relief

Clinically proven to moisturize 24 hours

With 7 intensive moisturizers

With botanicals and antioxidant vitamins A, C & E

NET WT 3.5 OZ (99 g)

hydrocortisone-image
SIGNATURE CARE HYDROCORTISONE 
hydrocortisone lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:21130-166
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
HYDROCORTISONE (UNII: WI4X0X7BPJ) (HYDROCORTISONE - UNII:WI4X0X7BPJ) HYDROCORTISONE1 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
OAT (UNII: Z6J799EAJK)  
LEVOMENOL (UNII: 24WE03BX2T)  
INDIAN FRANKINCENSE (UNII: 4PW41QCO2M)  
CETYL ALCOHOL (UNII: 936JST6JCN)  
ICODEXTRIN (UNII: 2NX48Z0A9G)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
DIPROPYLENE GLYCOL (UNII: E107L85C40)  
EDETATE DISODIUM (UNII: 7FLD91C86K)  
GLYCERIN (UNII: PDC6A3C0OX)  
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
ISOHEXADECANE (UNII: 918X1OUF1E)  
MAGNESIUM ASCORBYL PHOSPHATE (UNII: 0R822556M5)  
MALTODEXTRIN (UNII: 7CVR7L4A2D)  
METHYL GLUCETH-20 (UNII: J3QD0LD11P)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
PETROLATUM (UNII: 4T6H12BN9U)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
POLYSORBATE 60 (UNII: CAL22UVI4M)  
PROPYLPARABEN (UNII: Z8IX2SC1OH)  
WATER (UNII: 059QF0KO0R)  
VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)  
SODIUM CITRATE (UNII: 1Q73Q2JULR)  
GINGER (UNII: C5529G5JPQ)  
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:21130-166-251 in 1 CARTON08/10/2018
199 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34808/10/2018
Labeler - Safeway (009137209)

Revised: 8/2018
Document Id: 9fe16fc5-77e3-47f5-a943-85bc6565c0d4
Set id: 9fe16fc5-77e3-47f5-a943-85bc6565c0d4
Version: 1
Effective Time: 20180822
 
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