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

1% Hydrocortisone Anti-Itch Ointment

Maximum Strength

Immediately Soothes & Relieves Itch & Irritiation

Skin irritation

Skin Rashes

Insect Bites

Eczema

Psoriasis

Poison Ivy

Up to 12 hours Significant Itch Relief

Clinically Proven

Dermatologist Recommended Brand

Helps Heal the Itch

Lasts up to 12 hours

Immediately soothes itchy spots to help skin heal

Fragrance free and Paraben free

aquaphoritchreliefctn
(click image for full-size original)
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: 05/2021 Beiersdorf Inc

Our database comes directly from the FDA’s central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA’s repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

Our database comes directly from the FDA's central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA's repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

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