OTC Medication Information: Eucerin Itch Relief Intensive Calming

EUCERIN ITCH RELIEF INTENSIVE CALMING- menthol lotion
Beiersdorf 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.

Menthol 0.1%

External analgesic lotion

Use for the temporary relief of itching associated with minor skin irritations.

For external use only.

When using this product avoid contact with eyes.

Stop use and ask a doctor if

• condition worsens
• symptoms last more than 7 days or clear up and occur again within a few days
• irritation occurs

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

Questions or comments 1 800 227 4703

Ingredients:

Water, Glycerin, Alcohol Denat., Hydrogenated Coco-Glycerides, Isopropyl Palmitate, Triisostearin,
Stearyl Alcohol, Laureth-9, Palmitic Acid, Stearic Acid, Distarch Phosphate, Dimethicone,
Glyceryl Stearate, Cetyl Alcohol, PEG-100 Stearate, Sorbitan Stearate, Arginine HCl, Tocopherol,
Ceramide NP, Sodium Citrate, Citric Acid, Myristic Acid, Arachidic Acid, Oleic Acid,
Benzyl Alcohol, Pentylene Glycol, Ethylhexylglycerin, 4-t-butylcyclohexanol,
Menthoxypropanediol, Carbomer, Sodium Hydroxide, Trisodium EDTA.Inactive Ingredients

Directions

Adults and children 8 years of age and older

• apply to affected area not more than 3 to 4 times daily

Children under 8 years of age

• consult a doctor

Eucerin

Itch Relief Intensive Calming Lotion

Dry, Itchy Skin

up to 12 hours itch relief

Immediately relieves and calms dry, itchy skin

Menthol External Analgesic Lotion

Soothing, cooling effect

Ceramide enriched

Fragrance and Dye Free

Dermatological skincare

EUCERIN ITCH RELIEF INTENSIVE CALMING menthol lotion

Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:10356-358 Route of Administration TOPICAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength MENTHOL (MENTHOL) MENTHOL 0.1 g in 100 mL

Inactive Ingredients Ingredient Name Strength CETYL ALCOHOL DIMETHICONE SODIUM CITRATE BENZYL ALCOHOL WATER GLYCERIN ALCOHOL PEG-100 STEARATE GLYCERYL MONOSTEARATE ETHYLHEXYLGLYCERIN CARBOMER 980 CITRIC ACID MONOHYDRATE SORBITAN MONOSTEARATE ARGININE HYDROCHLORIDE PENTYLENE GLYCOL 4-TERT-BUTYLCYCLOHEXANOL 3-((L-MENTHYL)OXY)PROPANE-1,2-DIOL SODIUM HYDROXIDE EDETATE TRISODIUM TOCOPHEROL CERAMIDE NP MYRISTIC ACID ARACHIDIC ACID OLEIC ACID TRIISOSTEARIN STEARYL ALCOHOL PALMITIC ACID STEARIC ACID HYDROGENATED COCO-GLYCERIDES ISOPROPYL PALMITATE POLIDOCANOL

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:10356-358-51 250 mL in 1 BOTTLE None 2 NDC:10356-358-29 14 mL in 1 BOTTLE None

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part348 06/15/2020

Labeler — Beiersdorf Inc (001177906)

Revised: 12/2022 Beiersdorf Inc