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NDC Code(s): 70223-001-01 - Packager: Elroselabs Inc.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: unapproved homeopathic
DISCLAIMER: This homeopathic product has not been evaluated by the Food and Drug Administration for safety or efficacy. FDA is not aware of scientific evidence to support homeopathy as effective.
Drug Label Information
Updated November 16, 2015
If you are a consumer or patient please visit this version.
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- PURPOSE
Topical Use for
Homeopathic treatment for Molluscum Contagiosum
- ACTIVE INGREDIENT
ACTIVE INGREDIENTS
SILICEA
CALCAREA CARBONICA
THUJA OIL
NATRUM MURIATICUM
KALI BROMATUM
SULPHUR
KALI MURIATICUM
- INACTIVE INGREDIENT
CROTON LECHLERI RESIN
EMULSIFYING WAX NF
POLYSORBATE 60
MAGNESIUM SULFATE, UNSPECIFIED
VEGETABLE GLYCERIN
ZINC OXIDE
DIMETHYL ISOSORBIDE
TEA TREE OIL
METHYL SALICYLATE
CLOVE OIL
MELISSA OFFICINALIS
OREGANO LEAF OIL
CEDRUS ATLANTICA BARK OIL
NIAOULI OIL
EUCALYPTUS CAMALDULENSIS LEAF OIL
COCONUT OIL -
DIRECTIONS
Clean infected skin area'.
Apply small amount (equal to lesion size) on each lesion.
Gently rub in circular motion leaving thin cream layer.
Repeat treatment 2 to 3 times daily.
Let dry for 3 minutes.
-
USE
Molluscum Contagiosum lesion relief.
- WARNINGS
WARNINGS
For external use only. Do not use on large areas of the body, wounds, punctured skin, in eyes or animal bites or burns.
Stop use and ask doctor if rash or allergic reaction occurs / condition worsens.
- KEEP OUT OF REACH OF CHILDREN
KEEP OUT OF REACH OF CHILDREN.
If swallowed induce vomit.
- OTHER SAFETY INFORMATION
Store below 30°c (86°f)
Do not freeze or refrigerate.
Discard 6 month after opening.
- PRINCIPAL DISPLAY PANEL
- INGREDIENTS AND APPEARANCE
ELROSELABS
conzerol creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:70223-001 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength POTASSIUM CHLORIDE (UNII: 660YQ98I10) (CHLORIDE ION - UNII:Q32ZN48698) POTASSIUM CHLORIDE 6[hp_X] in30g SULFUR (UNII: 70FD1KFU70) (SULFUR - UNII:70FD1KFU70) SULFUR 3[hp_X] in30g POTASSIUM BROMIDE (UNII: OSD78555ZM) (BROMIDE ION - UNII:952902IX06) POTASSIUM BROMIDE 6[hp_X] in30g SILICON DIOXIDE (UNII: ETJ7Z6XBU4) (SILICON DIOXIDE - UNII:ETJ7Z6XBU4) SILICON DIOXIDE 6[hp_C] in30g OYSTER SHELL CALCIUM CARBONATE, CRUDE (UNII: 2E32821G6I) (OYSTER SHELL CALCIUM CARBONATE, CRUDE - UNII:2E32821G6I) OYSTER SHELL CALCIUM CARBONATE, CRUDE 6[hp_C] in30g SODIUM CHLORIDE (UNII: 451W47IQ8X) (CHLORIDE ION - UNII:Q32ZN48698) SODIUM CHLORIDE 6[hp_X] in30g Inactive Ingredients Ingredient Name Strength MAGNESIUM SULFATE, UNSPECIFIED (UNII: DE08037SAB) METHYL SALICYLATE (UNII: LAV5U5022Y) CLOVE OIL (UNII: 578389D6D0) CEDRUS ATLANTICA BARK OIL (UNII: ZX5QRE4U60) OREGANO LEAF OIL (UNII: 7D0CGR40U1) NIAOULI OIL (UNII: D50IC2T8FU) COCONUT OIL (UNII: Q9L0O73W7L) WHITE WAX (UNII: 7G1J5DA97F) POLYSORBATE 60 (UNII: CAL22UVI4M) GLYCERIN (UNII: PDC6A3C0OX) ZINC OXIDE (UNII: SOI2LOH54Z) TEA TREE OIL (UNII: VIF565UC2G) MELISSA OFFICINALIS (UNII: YF70189L0N) CROTON LECHLERI RESIN (UNII: GGG6W25C63) EUCALYPTUS CAMALDULENSIS LEAF OIL (UNII: SN6D1J15I6) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:70223-001-01 1 g in 1 CARTON; Type 0: Not a Combination Product 01/06/2016 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved homeopathic 12/10/2015 Labeler -Elroselabs Inc.(079977784)
Registrant -Elroselabs Inc. (079977784)
Establishment Name Address ID/FEI Business Operations Elroselabs Inc. 079977784 manufacture(70223-001)
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ELROSELABS- conzerol cream
Number of versions: 1
| Published Date (What is this?) | Version | Files |
|---|---|---|
| Jan 11, 2016 | 1 (current) | download |
RxNorm
ELROSELABS- conzerol cream
Under Review - Editing is pending for RxNorm. If in scope, these drugs will include RxNorm normal forms when editing is complete.
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ELROSELABS- conzerol cream
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NDC Codes
ELROSELABS- conzerol cream
If this SPL contains inactivated NDCs listed by the FDA initiated compliance action, they will be specified as such.
| NDC | |
|---|---|
| 1 | 70223-001-01 (inactivated) |
