Label: FIRST AID- calendula officials, stellaria media, st. johns wort, rosemary oil, plantago major, commiphora myrrha, comfrey leaf, salvia officinalis, sunflower oil salve
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NDC Code(s):
70994-101-01,
70994-101-02,
70994-101-04,
70994-101-08, view more70994-101-09, 70994-101-10
- Packager: Spry Life LLC
- 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 January 28, 2025
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- 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 • cuts • scrapes • abrasions • bruises • blisters • burns
▪︎ 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 irritations and itching due to • insect bites • poison ivy • sunburns• rashes caused by soaps, detergents, cosmetics, or jewelry
▪︎ temporarily protects and helps relieves minor pain associated with • abrasions • bruises • blisters • cuts • minor burns • sunburns• scrapes
- Keep out of reach of children section
- Warnings Section
- Storage
- Dosage & Administration Section
- Inactive Ingredients
- Principal Display Panel
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INGREDIENTS AND APPEARANCE
FIRST AID
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:70994-101 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 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 COMFREY LEAF (UNII: DG4F8T839X) (COMFREY LEAF - UNII:DG4F8T839X) COMFREY LEAF 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) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:70994-101-04 17 g in 1 TUBE; Type 0: Not a Combination Product 01/10/2023 2 NDC:70994-101-09 1 in 1 BOX 04/01/2016 2 NDC:70994-101-01 19.8 g in 1 CAN; Type 0: Not a Combination Product 3 NDC:70994-101-10 1 in 1 BOX 04/01/2016 3 NDC:70994-101-02 51.7 g in 1 CAN; Type 0: Not a Combination Product 4 NDC:70994-101-08 113 g in 1 JAR; Type 0: Not a Combination Product 04/01/2019 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved homeopathic 04/01/2016 Labeler - Spry Life LLC (100791947)