EXTRA STRENGTH PAIN RELIEF CREAM- menthol cream 
Sagely Enterprises Inc.

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Extra Strength Pain Relief Cream

Active ingredient

Menthol 10%

Purpose

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

Uses

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

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

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

Sagely Naturals

Extra Strength Pain Relief Cream

Instant Cooling

With 10% Menthol

95% Natural Ingredients

4 FL OZ / 118 ML

1

2

1

2

EXTRA STRENGTH PAIN RELIEF CREAM 
menthol cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:82075-415
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL10 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:82075-415-151 in 1 CARTON07/02/2021
1118 g in 1 BOTTLE, PUMP; Type 0: Not a Combination Product
2NDC:82075-415-001 in 1 CARTON11/19/2021
288 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34807/02/2021
Labeler - Sagely Enterprises Inc. (117049032)
Establishment
NameAddressID/FEIBusiness Operations
Verde Cosmetic Labs, LLC080656433manufacture(82075-415)

Revised: 11/2021
Document Id: d12a2843-3621-0449-e053-2995a90af52a
Set id: c6264c23-5803-324c-e053-2a95a90a9719
Version: 2
Effective Time: 20211119
 
Sagely Enterprises Inc.