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NDC 71397-0821-75 ACNE SPOT REPAIR 100 mg/g Details

ACNE SPOT REPAIR 100 mg/g

ACNE SPOT REPAIR is a TOPICAL LOTION in the HUMAN OTC DRUG category. It is labeled and distributed by menScience Androceuticals, LLC. The primary component is BENZOYL PEROXIDE.

MedlinePlus Drug Summary

Benzoyl peroxide is used to treat mild to moderate acne.

Related Packages: 71397-0821-75
Last Updated: 12/01/2022
MedLinePlus Full Drug Details: Benzoyl Peroxide Topical

Product Information

NDC	71397-0821
Product ID	71397-821_4dec259d-1ff9-44f2-e054-00144ff8d46c
Associated GPIs
GCN Sequence Number	n/a
GCN Sequence Number Description	n/a
HIC3	n/a
HIC3 Description	n/a
GCN	n/a
HICL Sequence Number	n/a
HICL Sequence Number Description	n/a
Brand/Generic	n/a
Proprietary Name	ACNE SPOT REPAIR
Proprietary Name Suffix	n/a
Non-Proprietary Name	BENZOYL PEROXIDE
Product Type	HUMAN OTC DRUG
Dosage Form	LOTION
Route	TOPICAL
Active Ingredient Strength	100
Active Ingredient Units	mg/g
Substance Name	BENZOYL PEROXIDE
Labeler Name	menScience Androceuticals, LLC
Pharmaceutical Class	n/a
DEA Schedule	n/a
Marketing Category	OTC MONOGRAPH FINAL
Application Number	part333D
Listing Certified Through	2022-12-31

Package

Package Images

NDC 71397-0821-75 (71397082175)

Pricing Information	N/A
NDC Package Code	71397-821-75
Billing NDC	71397082175
Package	21 g in 1 BOTTLE (71397-821-75)
Marketing Start Date	2017-04-20
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL 4dec259d-1ff5-44f2-e054-00144ff8d46c Details

Drug Facts

Active Ingredient

Benzoyl Peroxide 10%

Purpose

Acne Treatment

Uses

for the treatment and prevention of acne

Warnings

For external use only.

Do not use:

If you have very sensitive skin or are sensitive to benzoyl peroxide

When using this product:

Apply to affected areas only
Avoid unnecessary sun exposure and use a sunscreen
Do not use in or near the eyes, lips or mouth
This product may bleach hair or dyed fabrics
Using other topical acne medications at the same time or right after use of this product may increase dryness or irritation of the skin

Discontinue use and ask a doctor

If skin irritation becomes severe or if you are using more than one acne medication

Keep out of reach of children.

If swallowed, get medical help or contact a poison control center right away.

Directions:

Clean the skin before applying
Cover only acne spot with a thin layer 1 to 3 times daily
Because too much drying of the skin may occur, start with 1 application daily, then gradually increase to 2 or 3 times daily if needed or as directed by a doctor
If dryness or peeling occurs, reduce application to once a day or every other day.
If going outside, allow product to dry, then use a sunscreen
Store at 20-25°C (68-77°F)

Inactive Ingredients

Aqua purificata, c12-15 alkyl benzoate, urea, butylene glycol, cyclopentasiloxane, magnesium aluminum silicate, steareth-20, peg-100 stearate, zea mays, hydroxyethyl acrylate/sodium acryloyldimethyl, taurate copolymer, squalane, polysorbate 60, chamomilla recutita extract, camellia oleifera leaf extract, phospholipids, retinyl palmitate, tocopherol, ascorbyl palmitate, beta-carotene, ethylhexylglycerin, cetearyl alcohol, glycerin, caprylyl glycol, dimethicone, acrylates/c10-30 alkly acrylate crosspolymer, steareth-2, butylene glycol, propylene glycol, panthenol, disodium EDTA, allantoin, phytonadione.

Package Labeling:

INGREDIENTS AND APPEARANCE

ACNE SPOT REPAIR

benzoyl peroxide lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:71397-821
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
BENZOYL PEROXIDE (UNII: W9WZN9A0GM) (BENZOYL PEROXIDE - UNII:W9WZN9A0GM)	BENZOYL PEROXIDE	100 mg in 1 g

Ingredient Name	Strength
Inactive Ingredients
WATER (UNII: 059QF0KO0R)
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)
UREA (UNII: 8W8T17847W)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)
MAGNESIUM ALUMINUM SILICATE (UNII: 6M3P64V0NC)
STEARETH-20 (UNII: L0Q8IK9E08)
PEG-100 STEARATE (UNII: YD01N1999R)
STARCH, CORN (UNII: O8232NY3SJ)
HYDROXYETHYL ACRYLATE/SODIUM ACRYLOYLDIMETHYL TAURATE COPOLYMER (100000 MPA.S AT 1.5%) (UNII: 86FQE96TZ4)
SQUALANE (UNII: GW89575KF9)
POLYSORBATE 60 (UNII: CAL22UVI4M)
MATRICARIA CHAMOMILLA (UNII: G0R4UBI2ZZ)
CAMELLIA OLEIFERA LEAF (UNII: 5077EL0C60)
LECITHIN, SOYBEAN (UNII: 1DI56QDM62)
VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)
TOCOPHEROL (UNII: R0ZB2556P8)
ASCORBYL PALMITATE (UNII: QN83US2B0N)
.BETA.-CAROTENE (UNII: 01YAE03M7J)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
GLYCERIN (UNII: PDC6A3C0OX)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
DIMETHICONE (UNII: 92RU3N3Y1O)
STEARETH-2 (UNII: V56DFE46J5)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
PANTHENOL (UNII: WV9CM0O67Z)
EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)
ALLANTOIN (UNII: 344S277G0Z)
PHYTONADIONE (UNII: A034SE7857)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:71397-821-75	21 g in 1 BOTTLE; Type 0: Not a Combination Product	04/20/2017

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part333D	04/20/2017

Labeler - menScience Androceuticals, LLC (017390110)

Revised: 4/2017

Document Id: 4dec259d-1ff9-44f2-e054-00144ff8d46c

Set id: 4dec259d-1ff5-44f2-e054-00144ff8d46c

Version: 1

Effective Time: 20170424