BETTER NATURE PAIN RELIEF BALMX- capsaicin cream

Better Nature Pain Relief BalmX by

Drug Labeling and Warnings

Better Nature Pain Relief BalmX by is a Otc medication manufactured, distributed, or labeled by Better Nature Pty Ltd, WILD CHILD W A PTY LTD. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredients

Capsicum Oleoresin 0.25%

(Containing Capsaicin 0.1%)

Purpose

Capsicum Oleoresin 0.25%................Topical Analgesic

(Containing Capsaicin 0.1%)

Uses

Temporarily relieves minor pain associated with:

• arthritis
• simple backache
• strains
• sprains
• bruises

Warnings

For external use only

Do not use if

• you are allergic to salicylates (including aspirin) unless directed by doctor
• skin is infected or damaged
• excessive irritation develops
• 12 years of age or under.

When using this product

• use only as directed
• avoid contact with eyes or mucous membranes
• do not apply to wounds, damaged, broken or irritated skin
• do not bandage tightly or use a heating pad.

Stop and ask doctor if

• condition worsens
• symptoms persist for more than 7 days or clear up and occur again within days
• redness develops.

• If pregnant or breastfeeding, ask a healthcare professional before use.

Keep out of reach of children. If swallowed, contact a physician or contact a Poison Control Center immediately.

Directions

• Adults and children 13 years of age and older: apply to affected area not more than 3 to 4 times daily.

Children under 13 years of age: consult a physician.

Other information

• Store between 15C (59F) and 30C(86F) with the cap closed
• Notice: Colour may vary.

Inactive ingredients

arnica oil, beeswax, black pepper oil, cetostearyl alcohol, d-alpha-tocopherol (vitamin e), eucalyptus oil, glycerin, grapefruit oil, jojoba oil, lavander oil, lecithin, macadamia oil, olive oil, orange oil, rice bran oil, rosemary oil, soybean oil, st. johns' wort oil, sunflower oil and wintergreen oil.

Questions or comments?

Call toll free 1-800-720-5801

Adverse Event Reporting contact 1-800-222-1222

Better Nature

Better Nature

Pain Relief BalmX

100% Naturally Sourced

With Capsicum Oleoresin

WARMING

Australian Made

Net Wt. 2.64oz (75g)

INGREDIENTS AND APPEARANCE

BETTER NATURE PAIN RELIEF BALMX 
capsaicin cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 73454-001
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
CAPSAICIN (UNII: S07O44R1ZM) (CAPSAICIN - UNII:S07O44R1ZM)	CAPSAICIN	1 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
LECITHIN, SOYBEAN (UNII: 1DI56QDM62)
SOYBEAN OIL (UNII: 241ATL177A)
HYPERICUM OIL (UNII: OZU2FC70HY)
SUNFLOWER OIL (UNII: 3W1JG795YI)
GRAPEFRUIT OIL (UNII: YR377U58W9)
ORANGE OIL (UNII: AKN3KSD11B)
JOJOBA OIL (UNII: 724GKU717M)
LAVENDER OIL (UNII: ZBP1YXW0H8)
YELLOW WAX (UNII: 2ZA36H0S2V)
.ALPHA.-TOCOPHEROL, D- (UNII: N9PR3490H9)
EUCALYPTUS OIL (UNII: 2R04ONI662)
GLYCERIN (UNII: PDC6A3C0OX)
MACADAMIA OIL (UNII: 515610SU8C)
OLIVE OIL (UNII: 6UYK2W1W1E)
RICE BRAN OIL (UNII: LZO6K1506A)
ROSEMARY OIL (UNII: 8LGU7VM393)
ARNICA MONTANA FLOWER (UNII: OZ0E5Y15PZ)
METHYL SALICYLATE (UNII: LAV5U5022Y)
BLACK PEPPER OIL (UNII: U17J84S19Z)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 73454-001-75	1 in 1 CARTON	12/02/2019
1		75 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part348	12/02/2019

Labeler - Better Nature Pty Ltd (745189065)

Establishment
Name	Address	ID/FEI	Business Operations
WILD CHILD W A PTY LTD		744660692	manufacture(73454-001)