Label: STRETCH MARK CONTROL- calendula officinalis flower, hydrated silica, and allylthiourea solution/ drops
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Contains inactivated NDC Code(s)
NDC Code(s): 51393-4010-1, 51393-4010-2 - Packager: Forces of Nature
- 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 December 18, 2013
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- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- ACTIVE INGREDIENT
- Also Contains
- Indications
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Directions
Simply apply 2-4 drops of product to stretch marks and rub into the skin. Apply three times per day. Can also use as a preventative by applying to potential problem area 2-3 times per day. Product enhances skin elasticity thereby helping prevent stretch marks from forming. Shake bottle well before use.
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Warnings
As with any drug, if you are pregnant or breast-feeding, ask a health professional before use. Not for use on children under the age of 3.
For external use only. Some individuals may be sensitive to essential oils, skin test for tolerability. If accidental ingestion of more then several drops and adverse reactions occurs, get medical help or contact a Poison Control Center.
- SPL UNCLASSIFIED SECTION
- PRINCIPAL DISPLAY PANEL - 33 ml Bottle Label
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INGREDIENTS AND APPEARANCE
STRETCH MARK CONTROL
calendula officinalis flower, hydrated silica, and allylthiourea solution/ dropsProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:51393-4010 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Calendula Officinalis Flower (UNII: P0M7O4Y7YD) (Calendula Officinalis Flower - UNII:P0M7O4Y7YD) Calendula Officinalis Flower 6 [hp_X] in 100 mL Hydrated Silica (UNII: Y6O7T4G8P9) (Hydrated Silica - UNII:Y6O7T4G8P9) Hydrated Silica 6 [hp_X] in 100 mL Allylthiourea (UNII: 706IDJ14B7) (Allylthiourea - UNII:706IDJ14B7) Allylthiourea 8 [hp_C] in 100 mL Inactive Ingredients Ingredient Name Strength Helichrysum Italicum Flower Oil (UNII: O97ZV7726K) Rosa Canina Fruit Oil (UNII: CR7307M3QZ) Lavender Oil (UNII: ZBP1YXW0H8) Rosemary Oil (UNII: 8LGU7VM393) Sesame Oil (UNII: QX10HYY4QV) Product Characteristics Color YELLOW Score Shape Size Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:51393-4010-1 11 mL in 1 BOTTLE, DISPENSING 2 NDC:51393-4010-2 33 mL in 1 BOTTLE, DISPENSING Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date UNAPPROVED HOMEOPATHIC 03/15/2013 Labeler - Forces of Nature (050169130)
