4RLF TOPICAL ANALGESIC- menthol cream 
Rinati Skin, LLC

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.

----------

RINATI - JEUNESSE - 4RLF Topical Analgesic (76849-201)

ACTIVE INGREDIENTS

Menthol 0.10%

PURPOSE

TOPICAL ANALGESIC

USES

For the temporary relief of pain from minor burns, sunburn, minor cuts, scrapes, and insect bites.

WARNINGS

For external use only. When using this product ■ Avoid contact with eyes. In case of eye contact, flush eyes with water. ■ If condition worsens, or if symptoms persist for more than 7 days or clear up and occur again within a few days, discontinue use of this product and consult a physician.

■ Keep out of reach of children.

 If swallowed, get medical help.

DIRECTIONS FOR USE

■ Adults and children 2 years of age or older:
Apply to the desired area and gently rub into the skin, not more than
3 to 4 times daily. ■ Children under the age of 2: Consult a physician.

INACTIVE INGREDIENTS

Propylene Glycol, Ocimum Tenuiflorum Callus Culture Lysate, Glycerin, Dimethyl Sulfone, Water, Withania Somnifera Root Extract, Piper Nigrum (Pepper) Fruit Extract, Gluconolactone, Sodium Benzoate, Citric Acid, Xanthan Gum, Citrus Aurantium Dulcis (Orange) Oil, Hydroxyethylcellulose.

OTHER INFORMATION

■ Storage Instructions: Store in a cool, dark place (<100°F). Avoid storage directly in sunlight.

01b LBL_Rinati_4RLF_1mL.jpg

4RLF TOPICAL ANALGESIC 
menthol cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:76849-201
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL0.1 g  in 1 mL
Inactive Ingredients
Ingredient NameStrength
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
OCIMUM TENUIFLORUM WHOLE (UNII: 7OS52KZ33J)  
GLYCERIN (UNII: PDC6A3C0OX)  
DIMETHYL SULFONE (UNII: 9H4PO4Z4FT)  
WATER (UNII: 059QF0KO0R)  
WITHANIA SOMNIFERA ROOT (UNII: V038D626IF)  
PIPER NIGRUM WHOLE (UNII: 49L10LI8DN)  
GLUCONOLACTONE (UNII: WQ29KQ9POT)  
SODIUM BENZOATE (UNII: OJ245FE5EU)  
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
XANTHAN GUM (UNII: TTV12P4NEE)  
CITRUS AURANTIUM FRUIT OIL (UNII: 59JDQ5VT0T)  
CETYL HYDROXYETHYLCELLULOSE (350000 MW) (UNII: T7SWE4S2TT)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:76849-201-111 in 1 CARTON08/23/2021
110 in 1 BLISTER PACK
11 mL in 1 VIAL; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34808/23/2021
Labeler - Rinati Skin, LLC (109530208)

Revised: 10/2022
Document Id: ec20cbf3-a0b3-2173-e053-2995a90a3ddd
Set id: ee2832c7-6347-4c67-ac2b-579e6132afaa
Version: 6
Effective Time: 20221028
 
Rinati Skin, LLC