EXTRA STRENGTH PAIN RELIEF CREAM- menthol cream

Extra Strength Pain Relief Cream by

Drug Labeling and Warnings

Extra Strength Pain Relief Cream by is a Otc medication manufactured, distributed, or labeled by Sagely Enterprises Inc., Verde Cosmetic Labs, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredient

Menthol 10%

Purpose

Menthol 10%..............Topical analgesic

Uses

temporarily relieves the minor aches and pains of muscles and joints associated with:

• strains
• bruises
• simple backache
• arthritis
• sprains

Warnings

For external use only.

Do not use

• on wounds or damaged, broken, or irritated skin
• with a heating pad

When using this product

• avoid contact with eyes or mucous membranes
• do not bandage tightly

Stop use and ask a doctor if

• condition worsens or symptoms persist for more than 7 days or clear up and occur again wtihin a few days.

If pregnant or breastfeeding, ask a health professional before use.

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Directions

• Use only as directed
• Adults and children 12 years of age and older: apply to affected area not more than 3 to 4 times daily
• Children under 12 years of age: ask a doctor

Inactive ingredients

Water, Propanediol, Cetyl Alcohol, Caprylic/Capric Triglyceride, Stearyl Alcohol, Glycerin, Capryloyl Glycerin/Sebacic Acid Copolymer, Cetearyl Glucoside, Cetearyl Alcohol, Diheptyl Succinate, Xanthan Gum, Boswellia Serrata Resin Extract, Safflower (Carthamus Tinctorius) Seed Oil, Hemp (Cannabis Sativa) Seed Oil, Marula (Sclerocarya Birrea) Seed Oil, Argan (Argania Spinosa) Kernel Oil, Tocopheryl Acetate, Camphor, Peppermint (Mentha Piperita) Oil, Glyceryl Caprylate, Caprylhydroxamic Acid, Sodium Hydroxide

PRINCIPAL DISPLAY PANEL

Sagely Naturals

Extra Strength Pain Relief Cream

Instant Cooling

With 10% Menthol

95% Natural Ingredients

4 FL OZ / 118 ML

INGREDIENTS AND APPEARANCE

EXTRA STRENGTH PAIN RELIEF CREAM 
menthol cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 82075-415
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL	10 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
SAFFLOWER OIL (UNII: 65UEH262IS)
CANNABIS SATIVA SEED OIL (UNII: 69VJ1LPN1S)
PEPPERMINT OIL (UNII: AV092KU4JH)
GLYCERYL CAPRYLATE (UNII: TM2TZD4G4A)
CAPRYLHYDROXAMIC ACID (UNII: UPY805K99W)
PROPANEDIOL (UNII: 5965N8W85T)
WATER (UNII: 059QF0KO0R)
GLYCERIN (UNII: PDC6A3C0OX)
BOSWELLIA SERRATA RESIN OIL (UNII: 5T1XCE6K8K)
SCLEROCARYA BIRREA SEED OIL (UNII: WDO4TLS35F)
ARGAN OIL (UNII: 4V59G5UW9X)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
CETYL ALCOHOL (UNII: 936JST6JCN)
DIHEPTYL SUCCINATE (UNII: 057N7SS26Y)
CAMPHOR (NATURAL) (UNII: N20HL7Q941)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
STEARYL ALCOHOL (UNII: 2KR89I4H1Y)
CAPRYLOYL GLYCERIN/SEBACIC ACID COPOLYMER (2000 MPA.S) (UNII: N7YC58165T)
CETEARYL GLUCOSIDE (UNII: 09FUA47KNA)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
XANTHAN GUM (UNII: TTV12P4NEE)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 82075-415-15	1 in 1 CARTON	07/02/2021
1		118 g in 1 BOTTLE, PUMP; Type 0: Not a Combination Product
2	NDC: 82075-415-00	1 in 1 CARTON	11/19/2021
2		88 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	07/02/2021

Labeler - Sagely Enterprises Inc. (117049032)

Establishment
Name	Address	ID/FEI	Business Operations
Verde Cosmetic Labs, LLC		080656433	manufacture(82075-415)