SOOTHING FIRST AID CREAM cream

Soothing First Aid Cream by

Drug Labeling and Warnings

Soothing First Aid Cream by is a Homeopathic medication manufactured, distributed, or labeled by Homeo Health, Inc., OHM PHARMA INC.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENTS

• Active Ingredients (HPUS*):

  Purpose:

• Belladonna 4X:

  Relieves Sunburn Pain

• Calendula Officinalis 1X:

  Relieves Pain

• Cantharis 5X:

  Relieves Burning Pain

• Causticum 6X:

  Relieves Chapping, Raw Pain

• Hypericum Perforatum 1X:

  Relieves Pain

• Staphysagria 5X:

  Relieves Sharp Pains

USES

Uses: Temporarily relieves pain due to minor skin injuries such as scrapes and cuts. Supports healthy recovery.

WARNINGS

Warnings:

• For topical use only
• If pregnant or breast-feeding, ask a health care professional before use
• Keep out of the reach of children
• If symptoms persist or worsen, discontinue use and contact a health care professional
• In case of overdose (or accidental ingestion) get medical help or contact a Poison Control Center right away.

Keep out of the reach of children.

DIRECTIONS

Directions: For topical use only. Apply a small amount to affected area 3 times a day or as directed by a health care professional.

OTHER INFORMATION

Other Information: Do not use if cap seal is broken or missing. Store at room temperature.

INACTIVE INGREDIENTS

Inactive Ingredients*: Borax, Caprylyl Glycol, Coconut Oil, Emulsifying Wax NF, Organic Sunflower Oil, Phenoxyethanol, Purified Water, Vitamin E Oil.

* listed alphabetically

QUESTIONS OR COMMENTS?

Questions or Comments?

Homeo-Health, Inc.

Ph: (713) 366 8700

SPL UNCLASSIFIED SECTION

Mfg By:

OHM Pharma, Inc.

Made in USA

PRINCIPAL DISPLAY PANEL

NDC: 60914-001-00

NDC: 60914-001-01

NDC: 60914-001-02

HOMEO-HEALTH INC.

Homeopathic Remedies for Health

SOOTHING FIRST AID CREAM

Cuts, Burns, Scrapes

Soothing * Healing

TOPICAL HOMEOPATHIC

Net Wt: 0.49 oz (14 g)

Net Wt: 1.75 oz (50 g)

Net Wt: 3.35 oz (95 g)

Cuts, Burns, Scrapes

Soothing * Healing

INGREDIENTS AND APPEARANCE

SOOTHING FIRST AID CREAM 
soothing first aid cream cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 60914-001
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ATROPA BELLADONNA (UNII: WQZ3G9PF0H) (ATROPA BELLADONNA - UNII:WQZ3G9PF0H)	ATROPA BELLADONNA	4 [hp_X]  in 1 g
CALENDULA OFFICINALIS FLOWERING TOP (UNII: 18E7415PXQ) (CALENDULA OFFICINALIS FLOWERING TOP - UNII:18E7415PXQ)	CALENDULA OFFICINALIS FLOWERING TOP	1 [hp_X]  in 1 g
LYTTA VESICATORIA (UNII: 3Q034RO3BT) (LYTTA VESICATORIA - UNII:3Q034RO3BT)	LYTTA VESICATORIA	5 [hp_X]  in 1 g
CAUSTICUM (UNII: DD5FO1WKFU) (CAUSTICUM - UNII:DD5FO1WKFU)	CAUSTICUM	6 [hp_X]  in 1 g
HYPERICUM PERFORATUM (UNII: XK4IUX8MNB) (HYPERICUM PERFORATUM - UNII:XK4IUX8MNB)	HYPERICUM PERFORATUM	1 [hp_X]  in 1 g
DELPHINIUM STAPHISAGRIA SEED (UNII: 00543AP1JV) (DELPHINIUM STAPHISAGRIA SEED - UNII:00543AP1JV)	DELPHINIUM STAPHISAGRIA SEED	5 [hp_X]  in 1 g

Inactive Ingredients
Ingredient Name	Strength
SODIUM BORATE (UNII: 91MBZ8H3QO)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
COCONUT OIL (UNII: Q9L0O73W7L)
POLYSORBATE 60 (UNII: CAL22UVI4M)
SUNFLOWER OIL (UNII: 3W1JG795YI)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
WATER (UNII: 059QF0KO0R)
.ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 60914-001-02	95 g in 1 TUBE; Type 0: Not a Combination Product	09/22/2014
2	NDC: 60914-001-01	50 g in 1 TUBE; Type 0: Not a Combination Product	09/22/2014
3	NDC: 60914-001-00	14 g in 1 TUBE; Type 0: Not a Combination Product	09/22/2014

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved homeopathic		09/22/2014

Labeler - Homeo Health, Inc. (079158011)

Registrant - OHM PHARMA INC. (030572478)

Establishment
Name	Address	ID/FEI	Business Operations
OHM PHARMA INC.		030572478	manufacture(60914-001)