TOPICSKIN- hydrastis canadensis whole, mentha piperita, melissa officinalis cream

TopicSkin by

Drug Labeling and Warnings

TopicSkin by is a Homeopathic medication manufactured, distributed, or labeled by ZBM Natural Medicine Ltd., Emilia Cosmetics Ltd. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

Active Ingredients

Hydrastis canadensis L. 6X HPUS

Mentha piperita L. 6X HPUS

Melissa officinalis L. 6X HPUS

Purpose

Red, dry skin relief

Natural skin state restoration

Reddish skin color reduction Clearing of unpleasant patches

Uses

Helps relieve red, dry and irritated skin.

Helps clear away unpleasant reddish patches.

Helps restore the skin to its natural state.

Warnings

For external use only

Do not use

for any intended purpose other than indicated above.

When using this product

do not swallow keep away from eyes

do not use other external care products

If pregnant or breast-feeding

ask a health professional before use.

Keep out of reach of children

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

Directions

When using product for the first time, apply to a small area on the skin and wait for about 10 minutes. If there is no irritation, you may continue use.

For adults and children 6 months of age and over

For best results, apply the cream three times a day to clean skin.

Inactive Ingredients

WATER, SUNFLOWER (HELIANTHUS ANNUUS) SEED OIL, POLYACRYLAMIDE, C13-14 ISOPARAFFIN, LAURETH-7, GLYCERIN, SD ALCOHOL 40, DEHYDROACETIC ACID, BENZYL ALCOHOL, LACTIC ACID

SPL UNCLASSIFIED SECTION

The letters H.P.U.S. indicate that the components in this product are officially monographed in the Homeopathic Pharmacopoeia of the U.S. The letters ER indicate Eczema Relief.

Manufactured by:

Emilia Cosmetics LTD

Ha'mada 6, Yokneam

2069205, Israel

Made in Israel

Manufactured for:

ZBM Natural Medicine Ltd.

P.O. Box 2227

Industrial Zone

Kfar Saba 4464102

Israel

Package Label

TopicSkin

Special Cream

HOMEOPATHIC CREAM FOR THE RELIEF OF SYMPTOMS OF ECZEMA: RASH, BURNING, ITCHING, CHAPPED, DRY, OR CRACKED SKIN: MENTHA PIPERITA L., MELISSA OFFICINALIS L., AND HYDRASTIS CANADENSIS L.

2.54fl oz (75ml)

Original Herbal Formula

Paraben Free

Fragrance Free

Colorant Free

Dermatologically Tested

To report a serious adverse event, contact

(210) 880-4960

INGREDIENTS AND APPEARANCE

TOPICSKIN  
hydrastis canadensis whole, mentha piperita, melissa officinalis cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 69121-001
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
HYDRASTIS CANADENSIS WHOLE (UNII: R763EBH88T) (HYDRASTIS CANADENSIS WHOLE - UNII:R763EBH88T)	HYDRASTIS CANADENSIS WHOLE	6 [hp_X]  in 1 mL
MENTHA PIPERITA (UNII: 79M2M2UDA9) (MENTHA PIPERITA - UNII:79M2M2UDA9)	MENTHA PIPERITA	6 [hp_X]  in 1 mL
MELISSA OFFICINALIS (UNII: YF70189L0N) (MELISSA OFFICINALIS - UNII:YF70189L0N)	MELISSA OFFICINALIS	6 [hp_X]  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
SUNFLOWER OIL (UNII: 3W1JG795YI)
POLYACRYLAMIDE (10000 MW) (UNII: E2KR9C9V2I)
C13-14 ISOPARAFFIN (UNII: E4F12ROE70)
LAURETH-7 (UNII: Z95S6G8201)
GLYCERIN (UNII: PDC6A3C0OX)
DEHYDROACETIC ACID (UNII: 2KAG279R6R)
BENZYL ALCOHOL (UNII: LKG8494WBH)
LACTIC ACID (UNII: 33X04XA5AT)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 69121-001-75	75 mL in 1 TUBE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved homeopathic		11/10/2014

Labeler - ZBM Natural Medicine Ltd. (514481212)

Establishment
Name	Address	ID/FEI	Business Operations
Emilia Cosmetics Ltd		600076624	manufacture(69121-001)