OTC Medication Information: Aquaphor Itch Relief

AQUAPHOR ITCH RELIEF- hydrocortisone ointment
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.

Active Ingredient

Hydrocortisone 1%

Purpose

Anti-Itch Ointment

Uses

• for the temporary relief of itching associated with minor skin irritations, inflammation, and rashes due to:

• eczema
• insect bites
• soaps
• poison ivy, oak, sumac
• seborrheic dermatitis
• psoriasis
• detergents
• cosmetics
• jewelry

Warnings

For external use only

Do not use
• for the treatment of diaper rash. Consult a doctor.

When using this product
• avoid contact with eyes
• do not exceed the recommended daily dosage unless directed by a doctor

Stop use and consult a doctor if
• condition worsens, if symptoms persist for more than 7 days or clear
up and occur again within a few days,

and do not begin use of any other hydrocortisone product unless you have asked a doctor

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

Directions
Adults and children 2 years of age and older:
• Apply to affected area not more than 3 to 4 times daily.
Children under 2 years of age: Do not use, consult a doctor.

Inactive ingredients

Petrolatum, Mineral Oil, Ceresin, Lanolin Alcohol,
Panthenol, Glycerin, Bisabolol, Menthoxypropanediol

Questions or comments? 1-800-227-4703

Aquaphor Itch Relief Ointment

Maximum Strength

Immediately Soothes & Relieves Itch & Irritiation

Up to 12 hours Significant Itch Relief

Clinically Proven

1% Hydrocortisone Anti-Itch Ointment

Dermatologist Recommended Brand

Fragrance free and Paraben free

Hypoallergenic

Helps Heal the Itch

Clinically proven significant itch relief for up to 12 hours

Immediately soothes itchy spots to help skin heal

Skin irritation

Skin rashes

Eczema

Psoriasis

Eczema

Poison Ivy

Children’s

Aquaphor Itch Relief Ointment

Ages 2 Years and Older

Immediately Soothes & Relieves Itch & Irritiation

Up to 12 hours Significant Itch Relief

Clinically Proven

Number 1 Pediatrician Recommended Brand for Eczema

1% Hydrocortisone Anti-Itch Ointment

Dermatologist Recommended Brand

Fragrance free and Paraben free

Hypoallergenic

Helps Heal the Itch

Clinically proven significant itch relief for up to 12 hours

Immediately soothes itchy spots to help skin heal

Eczema

Skin irritation

Skin rashes

Psoriasis

Eczema

Poison Ivy

AQUAPHOR ITCH RELIEF hydrocortisone ointment

Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:10356-120 Route of Administration TOPICAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength HYDROCORTISONE (HYDROCORTISONE) HYDROCORTISONE 1 g in 100 g

Inactive Ingredients Ingredient Name Strength 3-((L-MENTHYL)OXY)PROPANE-1,2-DIOL MINERAL OIL CERESIN LANOLIN ALCOHOLS GLYCERIN PANTHENOL LEVOMENOL PETROLATUM

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:10356-120-30 0.9 g in 1 PACKET None 2 NDC:10356-120-52 1 TUBE in 1 CARTON contains a TUBE (10356-120-04) 2 NDC:10356-120-04 28 g in 1 TUBE This package is contained within the CARTON (10356-120-52) 3 NDC:10356-120-04 28 g in 1 TUBE None 4 NDC:10356-120-53 2 TUBE in 1 CARTON contains a TUBE (10356-120-04) 4 NDC:10356-120-04 28 g in 1 TUBE This package is contained within the CARTON (10356-120-53) 5 NDC:10356-120-54 1 TUBE in 1 CARTON contains a TUBE (10356-120-07) 5 NDC:10356-120-07 56 g in 1 TUBE This package is contained within the CARTON (10356-120-54) 6 NDC:10356-120-07 56 g in 1 TUBE None

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part348 11/01/2020

Labeler — Beiersdorf Inc (001177906)

Revised: 12/2022 Beiersdorf Inc