ZIMS ADVANCED CRACK CREME WITH HYDROCORTISONE- hydrocortisone cream

ZIMS ADVANCED CRACK CREME WITH HYDROCORTISONE by

Drug Labeling and Warnings

ZIMS ADVANCED CRACK CREME WITH HYDROCORTISONE by is a Otc medication manufactured, distributed, or labeled by NATURAL ESSENTIALS, INC.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

DRUG FACTS

ACTIVE INGREDIENT:

Hydrocortisone 1%

PURPOSE:

Anti-itch

USES:

Temporarily relieves itching associated with minor skin irritations

• inflammation and rashes due to:
  • eczema
  • psoriasis-poison ivy
  • oak
  • sumac
  • insect bites
  • detergents
  • jewelry
  • cosmetics
  • soaps
  • seborrheic
  • dermatitis
• Other uses of this product should be only under the advice and supervision of a doctor.

WARNINGS:

For external use only.

• When using this product avoid contact with the eyes
• do not use more than directed unless told to do so by a doctor
• do not put directly into the rectum by using fingers or any mechanical device or applicator

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:

• Adults and Children 2 Years of Age and Older:
• Apply to affected area not more than 2 to 3 times daily.
• Children Under 2 Years of Age: Ask a doctor.
• For External Anal and Genital Itching, Adults:
• When practical, dean the affected area with mild soap and warm water and rinse thoroughly.
• Gently dry by patting or blotting with toilet tissue or a soft doth before applying.
• Apply to affected area not more than 2 to 3 times dally.
• Children Under 12 Years of Age: Ask a doctor.
• Store at 20-25 degrees C / 68-77 degrees F.

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)

INGREDIENTS AND APPEARANCE

ZIMS ADVANCED CRACK CREME WITH HYDROCORTISONE 
hydrocortisone cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 66902-228
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
HYDROCORTISONE (UNII: WI4X0X7BPJ) (HYDROCORTISONE - UNII:WI4X0X7BPJ)	HYDROCORTISONE	10 mg  in 1 L

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 66902-228-03	1 in 1 TUBE
1		0.00085 L in 1 TUBE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part348	01/01/2014

Labeler - NATURAL ESSENTIALS, INC. (947484713)

Establishment
Name	Address	ID/FEI	Business Operations
NATURAL ESSENTIALS, INC.		947484713	MANUFACTURE(66902-228)