Drug Facts

Active ingredients

Colloidal Oatmeal 0.5%

Purpose

Skin Protectant

Uses

Temporarily protects and helps relieve minor skin irritation and itching due to eczema, rashes, poison ivy, oak or sumac, insect bites

Warnings

For external use only.

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

Do not get into 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

Directions

Apply as needed

Water, stearic acid, glycerin, c12-15 alkyl benzoate, caprylic/capric triglyceride, glyceryl stearate, glyceryl stearate SE, cetearyl alcohol, butyrospermum parkii (shea) butter, dimethicone, squalene, phenoxyethanol, caprylyl glycol. xanthan gum, allantoin, sodium hydroxide, tetrasodium EDTA, chrysanthemum parthenium (feverfew) extract, camellia sinensis leaf extract, citrus aurantium bergamia (bergamot) fruit extract, citrus aurantium dulcis (orange) peel extract, citrus grandis (grapefruit) peel extract, prunus armeniaca (apricot) fruit extract, rubus idaeus (raspberry) fruit extract, glycyrrhiza glabra (licorice) root extract, ceramide NP, cananga odorata flower extract, citrus aurantifolia (lime) peel extract, citrus aurantium amara (bitter orange) flower extract, cupressus sempervirens leaf/stem extract, mentha piperita (peppermint) leaf extract, pyrus malus (apple) fruit extract, rosmarinus officinalis (rosemary) leaf extract, salvia officinalis (sage) leaf extract, vanilla planifolia fruit extract.

Questions:

888-FAB-3063

MADE IN USA

FIRST AID BEAUTY LTD

NEWTON, MA 02458

WWW.FIRSTAIDBEAUTY.COM

PRINCIPAL DISPLAY PANEL - 14.0 oz (396.8 g)

First Aid Beauty

FAB

Ultra Repair® Cream

Intense Hydration

Skin Protectant Colloidal Oatmeal

White Tea + Apricto Natural Infusion

FIrst Aid Beauty ®

Net Wt. 14.0 oz (396.8 g)

FAB

FIRST AID BEAUTY FAB ULTRA REPAIR INTENSE HYDRATION SKIN PROTECTANT WHITE TEA AND APRICOT
colloidal oatmeal cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:69423-564
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
OATMEAL (UNII: 8PI54V663Y) (OATMEAL - UNII:8PI54V663Y)	OATMEAL	0.5 g in 100 g

Ingredient Name	Strength
Inactive Ingredients
CUPRESSUS SEMPERVIRENS LEAFY TWIG (UNII: 7HB6L93P3U)
MENTHA PIPERITA LEAF (UNII: A389O33LX6)
APPLE (UNII: B423VGH5S9)
SAGE (UNII: 065C5D077J)
CANANGA ODORATA FLOWER (UNII: 76GTF6Z97M)
CITRUS MAXIMA FRUIT RIND (UNII: 5NX3G75CA6)
TANACETUM PARTHENIUM WHOLE (UNII: 6GE7Z0761K)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
SQUALANE (UNII: GW89575KF9)
DIMETHICONE (UNII: 92RU3N3Y1O)
EDETATE DISODIUM (UNII: 7FLD91C86K)
GLYCERYL STEARATE SE (UNII: FCZ5MH785I)
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)
GREEN TEA LEAF (UNII: W2ZU1RY8B0)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
SHEA BUTTER (UNII: K49155WL9Y)
GLYCYRRHIZA GLABRA (UNII: 2788Z9758H)
WATER (UNII: 059QF0KO0R)
GLYCERIN (UNII: PDC6A3C0OX)
ALLANTOIN (UNII: 344S277G0Z)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
STEARIC ACID (UNII: 4ELV7Z65AP)
XANTHAN GUM (UNII: TTV12P4NEE)
ORANGE PEEL (UNII: TI9T76XD44)
CERAMIDE NP (UNII: 4370DF050B)
BERGAMOT OIL (UNII: 39W1PKE3JI)
ROSEMARY OIL (UNII: 8LGU7VM393)
VANILLA BEAN (UNII: Q74T35078H)
RASPBERRY (UNII: 4N14V5R27W)
LIME PEEL (UNII: 544EQK5Q0W)
CITRUS AURANTIUM FLOWER (UNII: O730ZX2Z83)
APRICOT (UNII: 269CJD5GZ9)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:69423-564-39	396.8 g in 1 JAR; Type 0: Not a Combination Product	01/01/2023

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	M016	01/01/2023

Labeler - The Procter & Gamble Manufacturing Company (004238200)