NDC | 70994-107-02, 70994-107-04, 70994-107-08, 70994-107-10 |
Set ID | 480f0858-1f69-057c-e054-00144ff88e88 |
Category | HUMAN OTC DRUG LABEL |
Packager | Sierra Sage Herbs LLC |
Generic Name | |
Product Class | |
Product Number | |
Application Number |
- Purpose Section
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Active Ingredients
Organic Calendula Officinalis (Calendula) Flower Oil 1X (HPUS)
Organic Plantago Major (Plantain) Leaf Extract 1X (HPUS)
Organic Stellaria Media (Chickweed) Extract 1X (HPUS)
Organic Symphytum Officinale (Comfrey) Leaf Powder 1X (HPUS)OrganicAchilleaMillefolium(Yarrow)Extract1X(HPUS)
Commiphora Myrrha (Myrrh) Resin 1X (HPUS)
Organic Salvia Officinalis (Sage) Leaf 1X (HPUS)
Organic Hypericum Perforatum (St. John’s Wort) Oil 1X (HPUS) -
Indications & Usage
■ temporarily protects minor ■ new tattoos
■ helps prevent and temporarily protects and helps relieve ■ chapped or cracked skin■ helps protect from the drying effects of wind and cold weather
■ temporarily protects and helps relieve minor skin irritation and itching due to ■ new tattoos■ temporarily protects and helps relieve minor pain associated with ■ new tattoos
- Keep out of reach of children section
- Warnings Section
- Storage
- Dosage & Administration Section
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Inactive Ingredients
Organic Aloe Barbadensis Leaf (Aloe Vera) Powder, Organic Olea Europaea (Olive) Fruit Oil, Organic Helianthus Annuus (Sunflower) Seed Oil, Organic Cera Alba (Beeswax), Styrax Benzoin Gum, Organic Larrea Tridentata (Chapparal) Extract, Tocopherol (Vitamin E), Lavandula Angustifolia (Lavender) Oil, Rosmarinus Officinalis (Rosemary) Leaf Oil.
- Principal Display Panel
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INGREDIENTS AND APPEARANCE
TATTOO CARE
calendula officials, stellaria media, st. johns wort, rosemary oil, plantago major, commiphora myrrha, comfrey leaf, salvia officinalis, sunflower oil salveProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:70994-107 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ACHILLEA MILLEFOLIUM FLOWER (UNII: YQR8R0SQEA) (ACHILLEA MILLEFOLIUM FLOWER - UNII:YQR8R0SQEA) ACHILLEA MILLEFOLIUM FLOWER 1 [hp_X] in 51.7 g ST. JOHN'S WORT (UNII: UFH8805FKA) (ST. JOHN'S WORT - UNII:UFH8805FKA) ST. JOHN'S WORT 1 [hp_X] in 51.7 g STELLARIA MEDIA (UNII: 2H03479QVR) (STELLARIA MEDIA - UNII:2H03479QVR) STELLARIA MEDIA 1 [hp_X] in 51.7 g CALENDULA OFFICINALIS FLOWER (UNII: P0M7O4Y7YD) (CALENDULA OFFICINALIS FLOWER - UNII:P0M7O4Y7YD) CALENDULA OFFICINALIS FLOWER 1 [hp_X] in 51.7 g COMFREY LEAF (UNII: DG4F8T839X) (COMFREY LEAF - UNII:DG4F8T839X) COMFREY LEAF 1 [hp_X] in 51.7 g PLANTAGO MAJOR (UNII: W2469WNO6U) (PLANTAGO MAJOR - UNII:W2469WNO6U) PLANTAGO MAJOR 1 [hp_X] in 51.7 g COMMIPHORA MYRRHA WHOLE (UNII: UU81N77RI7) (COMMIPHORA MYRRHA WHOLE - UNII:UU81N77RI7) COMMIPHORA MYRRHA WHOLE 1 [hp_X] in 51.7 g SALVIA OFFICINALIS WHOLE (UNII: M9C36LC10E) (SALVIA OFFICINALIS WHOLE - UNII:M9C36LC10E) SALVIA OFFICINALIS WHOLE 1 [hp_X] in 51.7 g Inactive Ingredients Ingredient Name Strength SUNFLOWER OIL (UNII: 3W1JG795YI) YELLOW WAX (UNII: 2ZA36H0S2V) LARREA TRIDENTATA LEAF (UNII: PK0TXD049P) ALPHA-TOCOPHEROL (UNII: H4N855PNZ1) ROSEMARY OIL (UNII: 8LGU7VM393) STYRAX BENZOIN RESIN (UNII: FE663Z8IRO) LAVENDER OIL (UNII: ZBP1YXW0H8) OLIVE OIL (UNII: 6UYK2W1W1E) ALOE VERA LEAF (UNII: ZY81Z83H0X) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:70994-107-10 1 in 1 BOX 04/01/2016 1 NDC:70994-107-02 51.7 g in 1 CAN; Type 0: Not a Combination Product 2 NDC:70994-107-08 113.4 g in 1 JAR; Type 0: Not a Combination Product 04/01/2016 3 NDC:70994-107-04 17 g in 1 TUBE; Type 0: Not a Combination Product 04/01/2016 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved homeopathic 04/01/2016 Labeler - Sierra Sage Herbs LLC (006970452)