BABY BALM- calendula officinalis, chamomilla recutita, archillea millefolium, symphytum officinalis, helianthus annuus salve 
Spry Life LLC

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.

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Baby Balm

OTC Purpose

Skin Protectant

Astringent

OTC Active Ingredients

Organic Achillea Millefolium (Yarrow) Flower Extract 1X (HPUS)

Organic Calendula Officinalis (Calendula) Flower Oil 1X (HPUS)

Organic Chamomilla Recutita (Matricaria) Flower 1X (HPUS
Organic Symphytum Officinale (Comfrey) Leaf Powder 1X (HPUS)

Indications & Usage

-temporarily protects minor • diapar rash • baby acne

-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 • cradle cap • diaper rash • baby acne • eczema • psoriasis • rashes

Warnings

Warnings

For external use only.

-Do not use on • on deep wounds • animal bites • serious burns

-Stop use and ask a doctor if • condition worsens • symptoms last more than 7 days or clear up and occur again within a few days

-When using this product keep out of eyes. Rinse with water to remove.

Keep Out of Reach of Children

Keep Out of Reach of Children

Storage and Handlin

Store at room temperature.

Dosage & Administration

Apply as often as needed to the affected area.

Inactive Ingredients

Organic Olea Europaea(Olive) Fruit Oil,Organic Cera Alba (Beeswax), Organic Helianthus Annuus (Sunflower) Seed Oil, Organic Simmondsia Chinensis (Jojoba) Seed Oil, Tocopherol (Vitamin E), Lavandula Angustifolia (Lavender) Oil.

Principal Display Panel

Baby Balm

BABY BALM 
calendula officinalis, chamomilla recutita, archillea millefolium, symphytum officinalis, helianthus annuus salve
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70994-501
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CALENDULA OFFICINALIS FLOWER (UNII: P0M7O4Y7YD) (CALENDULA OFFICINALIS FLOWER - UNII:P0M7O4Y7YD) CALENDULA OFFICINALIS FLOWER1 [hp_X]  in 51.7 g
SYMPHYTUM OFFICINALE WHOLE (UNII: H8FJJ6KX5Y) (SYMPHYTUM OFFICINALE WHOLE - UNII:H8FJJ6KX5Y) SYMPHYTUM OFFICINALE WHOLE1 [hp_X]  in 51.7 g
CHAMOMILE (UNII: FGL3685T2X) (CHAMOMILE - UNII:FGL3685T2X) CHAMOMILE1 [hp_X]  in 51.7 g
ACHILLEA MILLEFOLIUM FLOWER (UNII: YQR8R0SQEA) (ACHILLEA MILLEFOLIUM FLOWER - UNII:YQR8R0SQEA) ACHILLEA MILLEFOLIUM FLOWER1 [hp_X]  in 51.7 g
Inactive Ingredients
Ingredient NameStrength
YELLOW WAX (UNII: 2ZA36H0S2V)  
ALPHA-TOCOPHEROL (UNII: H4N855PNZ1)  
LAVENDER OIL (UNII: ZBP1YXW0H8)  
JOJOBA OIL (UNII: 724GKU717M)  
OLIVE OIL (UNII: 6UYK2W1W1E)  
SUNFLOWER OIL (UNII: 3W1JG795YI)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:70994-501-101 in 1 BOX04/01/2016
1NDC:70994-501-0251.7 g in 1 CAN; Type 0: Not a Combination Product
2NDC:70994-501-0417 g in 1 TUBE; Type 0: Not a Combination Product02/06/2019
3NDC:70994-501-08113.4 g in 1 JAR; Type 0: Not a Combination Product04/01/2016
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved homeopathic04/01/2016
Labeler - Spry Life LLC (100791947)

Revised: 12/2023
Document Id: 0dad439a-adfc-767e-e063-6394a90ac2e7
Set id: 48313e43-245f-5257-e054-00144ff8d46c
Version: 5
Effective Time: 20231229
 
Spry Life LLC