BLUE-EMU ANTI-ITCH CREAM- hydrocortisone 1% cream 
Nutrition & Fitness, Inc. DBA NFI Consumer Products, 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.

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NFI Consumer Products - Anti-Itch Cream (Hydrocortisone 1%) Drug Facts

ACTIVE INGREDIENT

Hydrocortisone 1%

PURPOSE

Anti-itch

USES

For the temporary relief of itching associated with minor skin irritations, inflammation and rashes due to:

  • eczema
  • insect bites
  • poison ivy
  • poison oak
  • psoriasis
  • seborrheic dermatitis
  • other uses of this product should only be under the advice and supervision of a doctor

WARNINGS

For external use only.

DO NOT USE

  • in or near the eyes
  • for diaper rash; ask a doctor

STOP USE AND ASK A DCTOR IF

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

KEEP OUT OF THE REACH OF CHILDREN

If swallowed, get medical help or contact a Poison Control Center right away.

DIRECTIONS

  • apply to affected area not more than 3 to 4 times daily
  • children under 2 years, do not use; ask a doctor.

OTHER INFORMATION

Store at room temperature.

Protect from freezing and excessive heat.

Keep carton as it contains important product information.

INACTIVE INGREDIENTS

acrylates/acrylamide copolymer, allantoin, aloe barbadensis (Aloe Vera) leaf juice, caprylic/capric triglyceride, cetyl alcohol, dimethicone, disodium edta, d-panthenol, emu oil ethylhexylglycerin, glycerin, glyceryl stearate, methyl glucose sesquistearate, mineral oil, peg-20 methyl glucose sesquistearate, peg-100 stearate, phenoxyethanol, polysorbate 80, polysorbate 85, sodium acrylate/sodium acryloyl dimethyl taurate copolymer, stearic acid, triethanolamine, tocopherol acetate (Vitamin E), water.

Carton Image

BLUE-EMU ANTI-ITCH CREAM 
hydrocortisone 1% cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69993-150
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
CARBOMER COPOLYMER TYPE A (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 71DD5V995L)  
ALLANTOIN (UNII: 344S277G0Z)  
MINERAL OIL (UNII: T5L8T28FGP)  
METHYL GLUCOSE SESQUISTEARATE (UNII: V1YW10H14D)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
WATER (UNII: 059QF0KO0R)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
EMU OIL (UNII: 344821WD61)  
CETYL ALCOHOL (UNII: 936JST6JCN)  
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
PEG-20 METHYL GLUCOSE SESQUISTEARATE (UNII: 0345752X7U)  
POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
POLYSORBATE 85 (UNII: A7F3N56197)  
SODIUM ACRYLATE (UNII: 7C98FKB43H)  
GLYCERIN (UNII: PDC6A3C0OX)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
EDETATE DISODIUM (UNII: 7FLD91C86K)  
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
PANTHENOL (UNII: WV9CM0O67Z)  
TROLAMINE (UNII: 9O3K93S3TK)  
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
Product Characteristics
ColorwhiteScore    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:69993-150-011 in 1 CARTON06/01/201510/31/2017
128 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 finalpart34806/01/201510/31/2017
Labeler - Nutrition & Fitness, Inc. DBA NFI Consumer Products, Inc. (016785052)

Revised: 2/2019
 
Nutrition & Fitness, Inc. DBA NFI Consumer Products, Inc.