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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Pain Relief Cream

Active ingredient

Menthol 5%

Purpose

Menthol 5%.................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 within 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

Pain Relief Cream

Instant Cooling

With 5% Menthol

95% Natural Ingredients

4 FL OZ / 118 ML 1

2

1

2

PAIN RELIEF CREAM 
menthol cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:82075-410
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL5 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
GLYCERIN (UNII: PDC6A3C0OX)  
BOSWELLIA SERRATA RESIN OIL (UNII: 5T1XCE6K8K)  
SAFFLOWER OIL (UNII: 65UEH262IS)  
CETEARYL GLUCOSIDE (UNII: 09FUA47KNA)  
XANTHAN GUM (UNII: TTV12P4NEE)  
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
CAMPHOR (NATURAL) (UNII: N20HL7Q941)  
CANNABIS SATIVA SEED OIL (UNII: 69VJ1LPN1S)  
ARGAN OIL (UNII: 4V59G5UW9X)  
GLYCERYL CAPRYLATE (UNII: TM2TZD4G4A)  
CAPRYLHYDROXAMIC ACID (UNII: UPY805K99W)  
PROPANEDIOL (UNII: 5965N8W85T)  
CAPRYLOYL GLYCERIN/SEBACIC ACID COPOLYMER (2000 MPA.S) (UNII: N7YC58165T)  
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
DIHEPTYL SUCCINATE (UNII: 057N7SS26Y)  
STEARYL ALCOHOL (UNII: 2KR89I4H1Y)  
WATER (UNII: 059QF0KO0R)  
CETYL ALCOHOL (UNII: 936JST6JCN)  
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
SCLEROCARYA BIRREA SEED OIL (UNII: WDO4TLS35F)  
PEPPERMINT OIL (UNII: AV092KU4JH)  
SODIUM HYDROXIDE (UNII: 55X04QC32I)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:82075-410-101 in 1 CARTON07/02/2021
1118 g in 1 BOTTLE, PUMP; Type 0: Not a Combination Product
2NDC:82075-410-951 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(82075-410)

Revised: 11/2021
Document Id: d12a5306-207c-1d50-e053-2995a90a04e4
Set id: c624fa53-c565-9114-e053-2a95a90acca3
Version: 3
Effective Time: 20211119
 
Sagely Enterprises Inc.