ZIMS ADVANCED HYDROCORTISONE CONTINUOUS WITH ORGANIC ARNICA AND ALOE by NATURAL ESSENTIALS, INC.

Drug Details [pdf]

ZIMS ADVANCED HYDROCORTISONE CONTINUOUS WITH ORGANIC ARNICA AND ALOE- hydrocortisone spray
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
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 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 clear 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, clean the affected area with mild soap and warm water and rinse thoroughly.
Gently dry by patting or blotting with toilet tissue or a soft cloth before applying.
Apply to affected area not more than 2 to 3 times daily.
Children Under 12 Years of Age: Ask a doctor.
Store at 20-25 degrees C / 68-77 degrees F.

INACTIVE INGREDIENTS:

Deionized water, Glycerine USP, Disodium EDTA, SDA Alcohol 39-C, Citric Acid, Aloe Vera, Arnica.

Principal Display Panel - Bottle Label

NEW!
ZIM'S
ADVANCED

Hydrocortisone
CONTINUOUS SPRAY

with Organic Arnica and Aloe

RASHES, INFLAMMATION,
REDNESS, INSECT BITES,

ECZEMA AND PSORIASIS

DEVELOPED BY A PHARMACIST

Net Wt. 3.25 oz (92.135g)

ZIMS ADVANCED HYDROCORTISONE CONTINUOUS WITH ORGANIC ARNICA AND ALOE
hydrocortisone spray

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 66902-229
Route of Administration	TOPICAL

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

Ingredient Name	Strength
Inactive Ingredients
WATER (UNII: 059QF0KO0R)
GLYCERIN (UNII: PDC6A3C0OX)
EDETATE DISODIUM (UNII: 7FLD91C86K)
ALCOHOL (UNII: 3K9958V90M)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
ARNICA MONTANA (UNII: O80TY208ZW)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC: 66902-229-04	0.0009215 L in 1 CAN; Type 0: Not a Combination Product	01/01/2014	12/31/2019
2	NDC: 66902-229-27	8E-05 L in 1 BLISTER PACK; Type 0: Not a Combination Product	01/01/2014	12/31/2019

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC MONOGRAPH NOT FINAL	part348	01/01/2014	12/31/2019

Labeler - NATURAL ESSENTIALS, INC. (947484713)

Revised: 4/2014

Document Id: 6fb849e9-f3ac-4b10-8189-38c3843282cd

Set id: bc8bd5ac-c66c-430f-b37c-5326082f214c

Version: 3

Effective Time: 20140407

NATURAL ESSENTIALS, INC.