AQUAPHOR ITCH RELIEF- hydrocortisone ointment

Aquaphor Itch Relief by

Drug Labeling and Warnings

Aquaphor Itch Relief by is a Otc medication manufactured, distributed, or labeled by Beiersdorf Inc. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active Ingredient

Hydrocortisone 1%

PURPOSE

Purpose

Anti-Itch Ointment

INDICATIONS & USAGE

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

Warnings

For external use only

DO NOT USE

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

WHEN USING

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

STOP USE

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

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

DOSAGE & ADMINISTRATION

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 INGREDIENT

Inactive ingredients

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

QUESTIONS

Questions or comments?
1-800-227-4703

PRINCIPAL DISPLAY PANEL

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

INGREDIENTS AND APPEARANCE

AQUAPHOR ITCH RELIEF 
hydrocortisone ointment

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

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
HYDROCORTISONE (UNII: WI4X0X7BPJ) (HYDROCORTISONE - UNII:WI4X0X7BPJ)	HYDROCORTISONE	1 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
3-((L-MENTHYL)OXY)PROPANE-1,2-DIOL (UNII: KD6TZ2QICH)
MINERAL OIL (UNII: T5L8T28FGP)
CERESIN (UNII: Q1LS2UJO3A)
LANOLIN ALCOHOLS (UNII: 884C3FA9HE)
GLYCERIN (UNII: PDC6A3C0OX)
PANTHENOL (UNII: WV9CM0O67Z)
LEVOMENOL (UNII: 24WE03BX2T)
PETROLATUM (UNII: 4T6H12BN9U)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 10356-120-30	0.9 g in 1 PACKET; Type 0: Not a Combination Product	11/01/2020
2	NDC: 10356-120-52	1 in 1 CARTON	11/01/2020
2	NDC: 10356-120-04	28 g in 1 TUBE; Type 0: Not a Combination Product
3	NDC: 10356-120-04	28 g in 1 TUBE; Type 0: Not a Combination Product	11/01/2020
4	NDC: 10356-120-53	2 in 1 CARTON	11/01/2020
4	NDC: 10356-120-04	28 g in 1 TUBE; Type 0: Not a Combination Product
5	NDC: 10356-120-54	1 in 1 CARTON	06/01/2021
5	NDC: 10356-120-07	56 g in 1 TUBE; Type 0: Not a Combination Product
6	NDC: 10356-120-07	56 g in 1 TUBE; Type 0: Not a Combination Product	06/01/2021

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M017	11/01/2020

Labeler - Beiersdorf Inc (001177906)