ZIMS ADVANCED CRACK CREME WITH HYDROCORTISONE- hydrocortisone cream 
NATURAL ESSENTIALS, 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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DRUG FACTS

ACTIVE INGREDIENT:

Hydrocortisone 1%

PURPOSE:

Anti-itch

USES:

Temporarily relieves itching associated with minor skin irritations

WARNINGS:

For external use only.

Stop use and ask a doctor if:

  • condition worsens, symptoms persist for more than 7 days clears up and occur again within a few days
  • do not begin use of any hydrocortisone product unless you have asked a doctor
  • If rectal bleeding occurs

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

DIRECTIONS:

For Itching of Skin Irritation, Inflammation, and Rashes:

INACTIVE INGREDIENTS:

Water, Aloe Barbadensis Leaf Juice, SD Alcohol 3-C, Propylene Glycol, Cetearyl Alcohol, Isocetyl Stearate, Caprylic/Capric Triglyceride, Pimenta Acris (Bay) Leaf Oil, Isostearyl Palmitate, Cetyi Palmitate, Arnica Montana Flower Extract, Carbomer, Glyceryl Stearate, Ceteth-20, PEG-100 Stearate, Triethanolamine, Disodium EDTA, Methylparaben, Diazolidinyl Urea, lodopropynyl Butylcarbamate.

Principal Display Panel - Tube Label

NEW!

ZIM'S®
ADVANCED

CRACK
CREME

Organic

ALOE AND
ARNICA
with HYDROCORTISONE

Dry, Cracked Skin
Rashes, Inflammation
Redness
Insect Bites
Eczema, Psoriasis

DEVELOPED BY A PHARMACIST

Net Wt 3 oz (85g)

Principal Display Panel - Tube Label
ZIMS ADVANCED CRACK CREME WITH HYDROCORTISONE 
hydrocortisone cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:66902-228
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
HYDROCORTISONE (UNII: WI4X0X7BPJ) (HYDROCORTISONE - UNII:WI4X0X7BPJ) HYDROCORTISONE10 mg  in 1 L
Inactive Ingredients
Ingredient NameStrength
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
ARNICA MONTANA (UNII: O80TY208ZW)  
BAY LEAF OIL (UNII: 5UMH0U3W0V)  
CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 4Q93RCW27E)  
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
CETYL ALCOHOL (UNII: 936JST6JCN)  
WATER (UNII: 059QF0KO0R)  
DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4)  
EDETATE DISODIUM (UNII: 7FLD91C86K)  
ALCOHOL (UNII: 3K9958V90M)  
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
IODOPROPYNYL BUTYLCARBAMATE (UNII: 603P14DHEB)  
ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)  
ISOPROPYL PALMITATE (UNII: 8CRQ2TH63M)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
PEG-100 STEARATE (UNII: YD01N1999R)  
POLYOXYL 20 CETOSTEARYL ETHER (UNII: YRC528SWUY)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
STEARYL ALCOHOL (UNII: 2KR89I4H1Y)  
STEARYL PALMITATE (UNII: 214W90O2XZ)  
TROLAMINE (UNII: 9O3K93S3TK)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:66902-228-031 in 1 TUBE
10.00085 L in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34801/01/2014
Labeler - NATURAL ESSENTIALS, INC. (947484713)
Establishment
NameAddressID/FEIBusiness Operations
NATURAL ESSENTIALS, INC.947484713MANUFACTURE(66902-228)

Revised: 3/2014
Document Id: 0a8f4510-8190-412d-90bc-d74df8cf65b9
Set id: fbdc6c18-9c1d-4b35-bb08-91bcdae8f983
Version: 1
Effective Time: 20140327
 
NATURAL ESSENTIALS, INC.