XENCARE INFLAMAX NATURAL TOPICAL PAIN- menthol, capsaicin cream

XENCARE INFLAMAX NATURAL TOPICAL PAIN by

Drug Labeling and Warnings

XENCARE INFLAMAX NATURAL TOPICAL PAIN by is a Otc medication manufactured, distributed, or labeled by Xenex Laboratories Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active Ingredients Purpose
Menthol 4% .................................................Topical Analgesic
Capsaicin 0.025% .........................................Topical Analgesic

INDICATIONS & USAGE

Uses
For the temporary relief of minor aches and
pains of muscles and joints associated
with:
Arthritis Simple backache Sprains
Bruises Strains

DOSAGE & ADMINISTRATION

Directions
Adults and children 2 years of age and
older Apply to affected area not more
than 3 to 4 times daily.
Children under 2 years of age Do not
use, consult a physician.

STORAGE AND HANDLING

Other Information

Store at room temperature.

INACTIVE INGREDIENT

Inactive Ingredients
Alcohol, Aloe Vera Leaf Extract, Ascorbyl
Palmitate, Caprylic/Capric Triglyceride,
Ceteareth-20, Cetearyl Alcohol, Cetyl
Alcohol, Coconut Oil, Diazolidinyl Urea,
Dimethicone, Edetate Disodium, Glycerin,
Glyceryl Stearate, Helianthus Annuus Seed
Wax, Iodopropynyl Butylcarbamate,
Isopropyl Myristate, Jojoba Esters,
Kawakawa Extract, Lecithin, Magnesium
Aluminum Silicate, Polyglycerin-3,
Safflower Oil, Sodium Stearoyl Glutamate,
Stearyl Alcohol, Turmeric Oil, Water,
Xanthan Gum.

WHEN USING

Warnings
For external use only.

When using this product
Avoid contact with eyes Do not apply to
open wounds or damaged skin
Avoid using under tight bandages.

Stop use and consult a physician if
symptoms persist for more than 7 days.

If pregnant or breast-feeding, ask a
healthcare professional before use.
Keep out of reach of children.
If swallowed, get medical help immediately.

STOP USE

Warnings
For external use only.

When using this product
Avoid contact with eyes Do not apply to
open wounds or damaged skin
Avoid using under tight bandages.

Stop use and consult a physician if
symptoms persist for more than 7 days.

If pregnant or breast-feeding, ask a
healthcare professional before use.
Keep out of reach of children.
If swallowed, get medical help immediately.

KEEP OUT OF REACH OF CHILDREN

Warnings
For external use only.

When using this product
Avoid contact with eyes Do not apply to
open wounds or damaged skin
Avoid using under tight bandages.

Stop use and consult a physician if
symptoms persist for more than 7 days.

If pregnant or breast-feeding, ask a
healthcare professional before use.
Keep out of reach of children.
If swallowed, get medical help immediately.

DO NOT USE

Warnings
For external use only.

When using this product
Avoid contact with eyes Do not apply to
open wounds or damaged skin
Avoid using under tight bandages.

Stop use and consult a physician if
symptoms persist for more than 7 days.

If pregnant or breast-feeding, ask a
healthcare professional before use.
Keep out of reach of children.
If swallowed, get medical help immediately.

PREGNANCY OR BREAST FEEDING

Warnings
For external use only.

When using this product
Avoid contact with eyes Do not apply to
open wounds or damaged skin
Avoid using under tight bandages.

Stop use and consult a physician if
symptoms persist for more than 7 days.

If pregnant or breast-feeding, ask a
healthcare professional before use.
Keep out of reach of children.
If swallowed, get medical help immediately.

PURPOSE

Uses
For the temporary relief of minor aches and
pains of muscles and joints associated
with:
Arthritis Simple backache Sprains
Bruises Strains

WARNINGS

Warnings
For external use only.

When using this product
Avoid contact with eyes Do not apply to
open wounds or damaged skin
Avoid using under tight bandages.

Stop use and consult a physician if
symptoms persist for more than 7 days.

If pregnant or breast-feeding, ask a
healthcare professional before use.
Keep out of reach of children.
If swallowed, get medical help immediately.

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

XENCARE INFLAMAX NATURAL TOPICAL PAIN 
menthol, capsaicin cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 68981-900
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
CAPSAICIN (UNII: S07O44R1ZM) (CAPSAICIN - UNII:S07O44R1ZM)	CAPSAICIN	0.025 g  in 100 g
LEVOMENTHOL (UNII: BZ1R15MTK7) (LEVOMENTHOL - UNII:BZ1R15MTK7)	LEVOMENTHOL	4 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
CAPRYLIC/CAPRIC TRIGLYCERIDE (UNII: C9H2L21V7U)
EDETATE DISODIUM (UNII: 7FLD91C86K)
KAWAKAWA (UNII: 106S546A3R)
JOJOBA OIL (UNII: 724GKU717M)
GLYCERYL STEARATE (UNII: 230OU9XXE4)
HELIANTHUS ANNUUS SEED WAX (UNII: 42DG15CHXV)
CETEARETH-20 (UNII: YRC528SWUY)
LECITHIN, SOYBEAN (UNII: 1DI56QDM62)
COCONUT OIL (UNII: Q9L0O73W7L)
CETEARYL ALCOHOL (UNII: 2DMT128M1S)
IODOPROPYNYL BUTYLCARBAMATE (UNII: 603P14DHEB)
SODIUM STEAROYL GLUTAMATE (UNII: 65A9F4P024)
XANTHAN GUM (UNII: TTV12P4NEE)
DIMETHICONE (UNII: 92RU3N3Y1O)
GLYCERIN (UNII: PDC6A3C0OX)
CETYL ALCOHOL (UNII: 936JST6JCN)
WATER (UNII: 059QF0KO0R)
STEARYL ALCOHOL (UNII: 2KR89I4H1Y)
ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)
TURMERIC OIL (UNII: 6KGS8SP16U)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
MAGNESIUM ALUMINUM SILICATE (UNII: 6M3P64V0NC)
POLYGLYCERIN-3 (UNII: 4A0NCJ6RD6)
ALCOHOL (UNII: 3K9958V90M)
SAFFLOWER OIL (UNII: 65UEH262IS)
ASCORBYL PALMITATE (UNII: QN83US2B0N)
DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4)

Product Characteristics
Color	white (White to yellowish white color)	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 68981-900-01	100 g in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	10/30/2024

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M017	10/30/2024

Labeler - Xenex Laboratories Inc. (209581065)