FLEXITOL FIRST AID- arnica montana flower and chamomile cream

FLEXITOL FIRST AID by

Drug Labeling and Warnings

FLEXITOL FIRST AID by is a Otc medication manufactured, distributed, or labeled by Laderma Trading Pty Ltd. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

ACTIVE INGREDIENT

* The letters H.P.U.S. indicate that the components in this product are officially monographed in the Homeopathic Pharmacopoeia of the United States.
Active ingredients	Purpose
Arnica Montana (6X H.P.U.S 0.2%)*	Healing Agent
Matricaria Recutita (6X H.P.U.S 0.2%)*	Healing Agent

Uses

• Helps promote healing of minor burns, poison ivy, abrasions and skin irritations
• Relieves sunburn and minor cuts

Warnings

• For External Use Only
• Avoid contact with eyes, mouth, ears, nose or other sensitive areas. If contact occurs, rinse area thoroughly with water.
• Keep out of reach of children
• If pregnant or breast-feeding, ask a health care professional before use.
• If condition worsens or does not improve after regular use of this product as directed, discontinue use and consult a physician
• Do not use if tube seal is broken or appears tampered with
• Always replace cap after use

Directions

• Apply a thin layer of cream and gently massage into affected area
• Use as required or as directed by a physician
  • For best results use in conjunction with Natralia First Aid Spray

Other Information

• Store between 50°-86°F in a dry place

Inactive Ingredients

Aloe Vera Powder, Avocado Oil, Capric/Caprylic Triglycerides, Caprylyl Glycol (and) Sorbic Acid (and) Phenoxyethanol, Carica Papaya (Paw Paw) Extract, Cetearyl Alcohol, Cetyl Palmitate (and) Sorbitan Palmitate (and) Sorbitan Olivate, Stellaria Media (Chickweed) Extract, Theobroma Cacao Butter, Evening Primrose Oil, Glyceryl Stearate, Glycyrrhiza Glabra (Licorice) Extract, Impatiens Cepenis (Jewelweed), Lavandula Angustifolia (Lavender) Oil, Butyrospermum Parkii (Shea Butter), Stearic Acid, Tocopheryl Acetate, Water, Zinc Oxide

Questions or Comments?

Call Toll Free 1-877-687-2542 usainfo@natrlia.com.au www.natralia.com.au/usa

Principal Display Panel - 1 oz Carton

NATRALIA
NATURALLY AUSTRALIAN™

For the relief of skin irritations such as:

• Cuts Minor Burns Abrasions Irritation:
  • Stings
  • Poison Ivy
  • Minor Rashes
  • Wounds

Net Wt 1oz (28g) e

INGREDIENTS AND APPEARANCE

FLEXITOL FIRST AID 
arnica montana flower and chamomile cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 43251-3363
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ARNICA MONTANA FLOWER (UNII: OZ0E5Y15PZ) (ARNICA MONTANA FLOWER - UNII:OZ0E5Y15PZ)	ARNICA MONTANA FLOWER	2 mg  in 1 g
CHAMOMILE (UNII: FGL3685T2X) (CHAMOMILE - UNII:FGL3685T2X)	CHAMOMILE	2 mg  in 1 g

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 43251-3363-8	1 in 1 CARTON
1		28 g in 1 TUBE
2	NDC: 43251-3363-9	0.85 g in 1 POUCH

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Unapproved drug other		03/12/2010

Labeler - Laderma Trading Pty Ltd (758651624)