Label: CALENDULA CREAM- calendula officinalis cream
ARNICA CREAM- arnica montana cream
- NDC Code(s): 62106-1177-0, 62106-1180-0
- Packager: Seroyal USA
- 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 April 12, 2022
If you are a consumer or patient please visit this version.
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- Official Label (Printer Friendly)
- ACTIVE INGREDIENT
- PURPOSE
- WARNINGS
- KEEP OUT OF REACH OF CHILDREN
- OVERDOSAGE
- INACTIVE INGREDIENT
- OTHER SAFETY INFORMATION
- DOSAGE & ADMINISTRATION
- INDICATIONS & USAGE
- ACTIVE INGREDIENT
- PURPOSE
-
WARNINGS
Warnings
For external use only.
Do not use
on irritated skin
if excessive irritation develops
When using this product, avoid getting
into eyes or mucous membranes.
Stop use and ask a doctor if symptoms
persist or worsen.
If pregnant or breastfeeding, 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. - KEEP OUT OF REACH OF CHILDREN
- OVERDOSAGE
- INACTIVE INGREDIENT
- OTHER SAFETY INFORMATION
- DOSAGE & ADMINISTRATION
- INDICATIONS & USAGE
- PRINCIPAL DISPLAY PANEL
- PRINCIPAL DISPLAY PANEL
-
INGREDIENTS AND APPEARANCE
CALENDULA CREAM
calendula officinalis creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:62106-1177 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength CALENDULA OFFICINALIS FLOWERING TOP (UNII: 18E7415PXQ) (CALENDULA OFFICINALIS FLOWERING TOP - UNII:18E7415PXQ) CALENDULA OFFICINALIS FLOWERING TOP 1 [hp_X] in 40 g Inactive Ingredients Ingredient Name Strength GLYCERIN (UNII: PDC6A3C0OX) CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S) WATER (UNII: 059QF0KO0R) ROSE OIL (UNII: WUB68Y35M7) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:62106-1177-0 1 in 1 CARTON 01/20/2015 1 40 g in 1 TUBE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved homeopathic 01/20/2015 ARNICA CREAM
arnica montana creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:62106-1180 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ARNICA MONTANA (UNII: O80TY208ZW) (ARNICA MONTANA - UNII:O80TY208ZW) ARNICA MONTANA 1 [hp_X] in 40 g CALENDULA OFFICINALIS FLOWERING TOP (UNII: 18E7415PXQ) (CALENDULA OFFICINALIS FLOWERING TOP - UNII:18E7415PXQ) CALENDULA OFFICINALIS FLOWERING TOP 1 [hp_X] in 40 g Inactive Ingredients Ingredient Name Strength CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S) GLYCERIN (UNII: PDC6A3C0OX) WATER (UNII: 059QF0KO0R) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:62106-1180-0 1 in 1 CARTON 01/20/2015 1 40 g in 1 TUBE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved homeopathic 01/20/2015 Labeler - Seroyal USA (018361118) Establishment Name Address ID/FEI Business Operations SAN'UP 401010287 manufacture(62106-1177, 62106-1180)